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Trial registered on ANZCTR
Registration number
ACTRN12624000882527
Ethics application status
Approved
Date submitted
25/06/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
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Scientific title
Validation of an Ovarian Adnexal Mass Assessment Score Test System in Women With an Ovarian Mass
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Secondary ID [1]
312401
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CT-2023-CTN-05057-1
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Universal Trial Number (UTN)
U1111-1309-8397
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
ovarian cancer
334210
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adnexal mass
334211
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benign ovarian mass
334212
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Condition category
Condition code
Cancer
330875
330875
0
0
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Ovarian and primary peritoneal
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Reproductive Health and Childbirth
330877
330877
0
0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study will benchmark the performance of the CleoDX Pre-Surgical triage Test against the use of CA125&transvaginal ultrasound to predict risk of malignancy prior to surgery in patients with an adnexal mass. Patients provide a single serum sample prior to surgical referral, in addition to that provided for standard-of-care tests. There is no patient follow-up required.
The CleoDX Pre-Surgical Test measures a combination of 5 biomarkers in serum (CA125, HE4, IL6, active CXCL10 and total CXCL10) from patients, and combines the result into a single score (from 1-10) as an indicator of malignancy risk. It is used to assist in the pre-surgical determination of likelihood that an adnexal mass may be malignant, and ensure triage to an appropriate surgical expertise for further evaluation.
The test will be indicated for use in patients in whom the presence of an adnexal mass requires surgical intervention, but who have not yet been seen by an oncologist. Typically these patients will have received ultrasound imaging and CA125 test, and the results of the test indicate referral to a surgeon for secondary evaluation is warranted.
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Intervention code [1]
328905
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Diagnosis / Prognosis
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Intervention code [2]
328906
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Early Detection / Screening
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Comparator / control treatment
As per standard of care, patients with a suspected adnexal mass undergo (i) transvaginal ultrasound and (ii) CA125 serum testing. These two standard tests are used to assist in determining the risk of malignancy, and refer patients to an appropriate secondary evaluation for surgical intervention. This testing occurs in a general clinical setting for every patient prior to referral.
This trial will access a single serum sample from patients who have already received standard of care testing, and are being referred for surgical evaluation. The serum sample will be accessed from a single blood draw provided at the time of referral, processed through a standard pathology provider network and then stored until sufficient numbers for batch analysis are obtained.
The result of serum testing using the CleoDX test will be retrospectively correlated with pathology findings, and its ability to pre-surgically differentiate benign from malignant masses compared to the initial indication obtained using standard-of-care CA125 and transvaginal ultrasound.
There is no intervention arising as a result of the test findings. The study is purely observational.
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Control group
Active
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Outcomes
Primary outcome [1]
338631
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Calculation of a CleoDX Pre-Surgical Triage Test malignancy risk score
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Assessment method [1]
338631
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CleoDX Pre-Surgical Triage Test malignancy risk score from serum assay (drawn pre-surgically)
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Timepoint [1]
338631
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Scores will be determined retrospectively on completion of study enrollment (anticipated maximum 1 year following surgery).
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Secondary outcome [1]
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Diagnostic sensitivity of CleoDX Pre-Surgical Triage Test malignancy risk score to identify cancer patients
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Assessment method [1]
437159
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Statistical analysis to determine sensitivity of the test to predict malignancy compared to the prediction made using CA125 & ultrasound findings.
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Timepoint [1]
437159
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Blood samples will be collected at enrollment prior to surgery.. Ultrasound reports and CA125 serum titre will be collected as they become available, which may occur before or after surgery. Any pathology findings will be collected after surgery and histopathological examination of any tissue removed.
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Secondary outcome [2]
437684
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Diagnostic specificity of CleoDX Pre-Surgical Triage Test malignancy risk score to identify cancer patients
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Assessment method [2]
437684
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Statistical analysis to determine specificity of the test to predict malignancy compared to the prediction made using CA125 & ultrasound findings.
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Timepoint [2]
437684
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Blood samples will be collected at enrollment prior to surgery.. Ultrasound reports and CA125 serum titre will be collected as they become available, which may occur before or after surgery. Any pathology findings will be collected after surgery and histopathological examination of any tissue removed.
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Eligibility
Key inclusion criteria
1. Female patients => 18 years of age at the time of consent
2. Can provide written informed consent
3. Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Pregnant currently / within the last 3 months
2. Current or previous ovarian cancer
3. Prior bilateral oophorectomy or otherwise in surgical menopause
4. Diagnosed with any gynecological malignancy within last 2 years
5. Diagnosed with melanoma within last 2 years
6. Current or prior (previous 12 months) treatment with chemotherapy, radiotherapy or immunotherapy
7. Immune-compromised – defined as those whose weakened immune system may render them more susceptible to infection, illness, or complications. These may include patients with immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-, chemo- or radio-therapy (within the last 12 months) for any reason, receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease), or with a primary immunodeficiency disorder (e.g. Lupus).
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/07/2024
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Actual
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Date of last participant enrolment
Anticipated
30/04/2026
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Actual
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Date of last data collection
Anticipated
31/07/2026
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26726
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Monash Medical Centre - Moorabbin campus - East Bentleigh
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Recruitment hospital [2]
26728
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
42773
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3165 - East Bentleigh
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Recruitment postcode(s) [2]
42775
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3168 - Clayton
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Recruitment outside Australia
Country [1]
26396
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United States of America
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State/province [1]
26396
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Funding & Sponsors
Funding source category [1]
316809
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Commercial sector/Industry
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Name [1]
316809
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Cleo Diagnostics Ltd
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Address [1]
316809
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Country [1]
316809
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Cleo Diagnostics Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
319038
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None
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Name [1]
319038
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Address [1]
319038
0
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Country [1]
319038
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315580
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
315580
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
315580
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Australia
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Date submitted for ethics approval [1]
315580
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07/12/2023
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Approval date [1]
315580
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03/04/2024
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Ethics approval number [1]
315580
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HREC/103505/MonH-2023-402747(v1)
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Summary
Brief summary
This study will evaluate a diagnostic test for cancer risk before surgery women with an ovarian mass Who is it for? You may be eligible to join this study if you are aged 18 years and above and have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination that requires surgery. You will already have had a CA125 test and a transvaginal ultrasound, and your doctor will have made a decision to send you to a specialist for further examination. Study details Cleo Diagnostics Ltd has developed a novel Ovarian Cancer Adnexal Mass Assessment Score test system. Participants in this study will have a single blood sample taken prior to surgery for testing using the novel Ovarian Cancer Adnexal Mass Assessment Score test system. This test measures five analytes in serum, and combines their values into a single score. This score indicates the likelihood that a mass might be malignant, before surgery is undertaken to determine the nature of the mass. In this trial the risk score will be compared to pathology findings after surgery, to retrospectively assess its accuracy to predict malignancy. It is hoped that the test will enhance clinical decision-making and assist in patient referral for further surgical exploration.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135142
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Prof Tom Jobling
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Address
135142
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c/o Monash Health Gynecological Oncology Unit 823-865 Centre Rd, Bentleigh East VIC 3165
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Country
135142
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Australia
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Phone
135142
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+613 9928 8243
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Fax
135142
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Email
135142
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[email protected]
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Contact person for public queries
Name
135143
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Leona Chan
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Address
135143
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c/o Hudson Institute of Medical Research, Level 3, 27-31 Wright St Clayton 3168
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Country
135143
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Australia
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Phone
135143
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+613 8572 2686
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Fax
135143
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Email
135143
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[email protected]
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Contact person for scientific queries
Name
135144
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Andrew Stephens
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Address
135144
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c/o Hudson Institute of Medical Research, Level 3, 27-31 Wright St Clayton 3168
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Country
135144
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Australia
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Phone
135144
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+613 8572 2686
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Fax
135144
0
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Email
135144
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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