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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02385214
Registration number
NCT02385214
Ethics application status
Date submitted
13/06/2014
Date registered
11/03/2015
Date last updated
14/04/2022
Titles & IDs
Public title
MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma
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Scientific title
A Phase III, Multi-centre, Multi-national Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma
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Secondary ID [1]
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03.12
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Universal Trial Number (UTN)
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Trial acronym
MelMarT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma by AJCC V7 Stage
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Wide Local Excision = 1cm Margin
Treatment: Surgery - Wide Local Excision = 2cm Margin
Experimental: Arm A Wide Local Excision = 1cm Margin - ARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy
+/- Reconstruction
Active comparator: Arm B Wide Local Excision = 2cm Margin - ARM B:Control Arm Wide Local Excision = 2cm Margin + Sentinel Lymph Node Biopsy
+/- Reconstruction
Treatment: Surgery: Wide Local Excision = 1cm Margin
A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.
Treatment: Surgery: Wide Local Excision = 2cm Margin
A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Local Melanoma Recurrence (Melanoma Specific Survival)
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Assessment method [1]
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Time from randomisation to clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes.
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Timepoint [1]
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0-120 months
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Secondary outcome [1]
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Recurrence-Free Survival
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Assessment method [1]
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Time from randomisation to any clinical, histological or radiologically confirmed melanoma recurrence or death from any cause.
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Timepoint [1]
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0-120 months
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Secondary outcome [2]
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QoL and neuropathic pain assessments Neuropathic Pain (PainDetect)
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Assessment method [2]
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Quality of Life
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Timepoint [2]
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Baseline, 3, 6 12, 24 & 60 months.
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Time from randomisation to death from any cause.
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Timepoint [3]
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0-120 Months
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Secondary outcome [4]
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Adverse events
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Assessment method [4]
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An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness.
AEs and any pre-existing medical conditions will be recorded at the Baseline assessment and routinely at Follow Up, until the participant completes the study, withdraws or dies.
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Timepoint [4]
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Within 1 year
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Secondary outcome [5]
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Surgery related adverse events
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Assessment method [5]
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The following surgical adverse events will be recorded from the time of trial treatment to 30 days following the wide excision (inclusive):
* wound separation
* seroma/haematoma at wide local excision site
* haemorrhage
* infection
* skin graft failure
* necrosis of flap used for reconstruction
* deep venous thrombosis
* urinary tract infection
* pneumonia
* cardiac complications
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Timepoint [5]
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Up to 30 days from randomisation
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Secondary outcome [6]
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Health System Resource Use
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Assessment method [6]
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All hospitalisations and other interventions will be captured in order to measure resource use.
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Timepoint [6]
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Baseline, 3, 6, 12, 24 and 60 months
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Eligibility
Key inclusion criteria
1. Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
2. Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.
3. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
4. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
5. Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.
6. Patients must be 18 years or older at time of consent.
7. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
8. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
9. Patients must have an ECOG performance score between 0 and 1.
10. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
* The patient has undergone potentially curative therapy for all prior malignancies,
* There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
* The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
2. Patient has already undergone wide local excision at the site of the primary index lesion.
3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
4. Desmoplastic or neurotropic melanoma.
5. Microsatellitosis as per AJCC 2009 definition
6. Subungual melanoma
7. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
8. History of previous or concurrent (i.e., second primary) invasive melanoma.
9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
12. Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.
13. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.
15. History of organ transplantation.
16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/08/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Melanoma Institute Australia - Poche Centre - North Sydney
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Recruitment hospital [2]
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Gold Coast Melanom Clinic - Coolangatta
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre Division of Cancer Surgery - Melbourne
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Recruitment hospital [4]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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4225 - Coolangatta
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Recruitment postcode(s) [3]
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3002 - Melbourne
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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Pennsylvania
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Canada
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Toronto
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Sweden
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Göteborg
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United Kingdom
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England
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United Kingdom
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Essex
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United Kingdom
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Mersyside
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United Kingdom
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Oxford
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Exeter
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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State/province [13]
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Norwich
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melanoma and Skin Cancer Trials Limited
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Peter MacCallum Cancer Centre, Australia
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Norfolk and Norwich University Hospitals NHS Foundation Trust
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas \>=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients
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Trial website
https://clinicaltrials.gov/study/NCT02385214
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marc Moncrieff
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Address
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Norfolk & Norwich University Hospital
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02385214
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