Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001249145
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
10/09/2019
Date last updated
28/06/2023
Date data sharing statement initially provided
10/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
CODEC Study-Circulating tumOur Dna in Endometrial Cancer
Scientific title
CODEC Study-Circulating tumOur Dna in Endometrial Cancer;An exploratory, pilot study to investigate the potential use of circulating tumour DNA as a novel blood-based prognostic biomarker and indicator of disease
Secondary ID [1] 298665 0
EH2016-158
Universal Trial Number (UTN)
U1111-1236-6295
Trial acronym
CODEC
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer 313562 0
Condition category
Condition code
Cancer 311991 311991 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients enrolled in the study will have comprehensive genomic tumour assessment and serial blood collections to facilitate analysis of circulating tumour DNA plus CA 125 and HE4 beginning pre-operatively and continuing for up to two years following surgery.

Pre-screening takes place when the patient is first diagnosed with endometrial cancer (pre-surgery, post biopsy procedure) and also involves a pre-operative MRI and PET scan. A repeat PET scan will also occur 12 months from the date of surgery.

If clinical relapse is suspected, a repeat blood collection and PET will be performed.

This is an observational study with no impact on treatment which is given at the clinician’s discretion.
Intervention code [1] 314933 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320636 0
Relapse free survival (from the date of surgery until the time of local recurrence, distant recurrence or death due to any cause, whichever occurs first)
Timepoint [1] 320636 0
Maximum 5 years
Primary outcome [2] 320637 0
Presence and level of pre-operative ctDNA (blood test)
Timepoint [2] 320637 0
Pre-surgery
Secondary outcome [1] 372278 0
Overall survival (from the time of surgery until death due to any cause. )
Timepoint [1] 372278 0
Maximum 5 years
Secondary outcome [2] 372279 0
Progression free survival ( from the time of surgery until the time of distant recurrence or death due to any cause )
Timepoint [2] 372279 0
Maximum 5 years
Secondary outcome [3] 372280 0
Relapse free survival at 12 months (% of participants free from local recurrence, distant recurrence or death due to any cause 12 months from surgery)
Timepoint [3] 372280 0
12 months from the time of surgery
Secondary outcome [4] 372281 0
Presence and level of ctDNA at each of the designated post-operative assessment time points
Timepoint [4] 372281 0
Perioperatively
2-6 weeks post surgery
Pre-adjuvant therapy
During adjuvant therapy
3 monthly for a maximum of 2 years from surgery
Secondary outcome [5] 372282 0
HE4 status (blood test) at each of the designated assessment time points
Timepoint [5] 372282 0
Pre- surgery
Perioperatively
2-6 weeks post surgery
3 monthly for a maximum of 2 years from the date of surgery
Secondary outcome [6] 372283 0
CA 125 status (blood test) at each of the designated assessment time points
Timepoint [6] 372283 0
Pre surgery
Perioperatively
2-6 weeks post surgery
3 monthly for a maximum of 2 years from the date of surgery
Secondary outcome [7] 372284 0
MRI findings at the pre-operative time point (exploratory)
Timepoint [7] 372284 0
Pre-screening
Secondary outcome [8] 372285 0
PET findings at the pre-operative and 12 month assessment time points (exploratory)
Timepoint [8] 372285 0
Pre-screening
12 months from surgery
Relapse (if applicable)

Eligibility
Key inclusion criteria
-Patients with Type 2* endometrial cancer on pipelle/curettage /endometrial biopsy procedure
-Planned for gynaecological surgery
-Consenting to the collection of bio-specimens, including blood and tissue
*Type 2 endometrial cancer includes the following histologies: serous, clear cell, carcinosarcoma, high-grade (grade 3) endometrioid.
Mixed tumours included if the Type 2 component (grade 3) is greater than or equal to 10% of the tumour.

-44% (20/45) of recruited patients must have at least one of the following high risk features on pre-op imaging:
i. Lymphadenopathy based on pre-op CT or MRI (Lymph node greater than or equal to 10 mm)
ii. Deeply invasive primary with invasion into the cervical stroma on MRI
iii. PET positive disease outside the primary based on pre-op PET
-Of the remaining patients (approximately 25), at least 36% (9) must have myometrial invasion greater than or equal to 50% on pre-op MRI
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Women with other active malignancy or a history of malignancy (excluding a completely resected superficial skin cancer or a cancer that was treated more than 2 years ago and remains in remission).
-Any participant that remains on anti-cancer treatment following a cancer diagnosis
-Women that have no residual high grade (grade 3) tumour at the time of resection (unless adequate DNA is available from the endometrial biopsy sample)
-Inability to consent due to cognitive impairment

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
3/04/2019
Date of last participant enrolment
Anticipated
2/04/2021
Actual
3/03/2022
Date of last data collection
Anticipated
5/04/2024
Actual
Sample size
Target
45
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14143 0
Epworth Freemasons (Victoria Parade) - East Melbourne
Recruitment hospital [2] 14144 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [3] 14145 0
Epworth Richmond - Richmond
Recruitment hospital [4] 14146 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 26955 0
3002 - East Melbourne
Recruitment postcode(s) [2] 26956 0
3128 - Box Hill
Recruitment postcode(s) [3] 26957 0
3121 - Richmond
Recruitment postcode(s) [4] 26958 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 303206 0
Charities/Societies/Foundations
Name [1] 303206 0
Epworth Medical Foundation
Country [1] 303206 0
Australia
Funding source category [2] 303207 0
Charities/Societies/Foundations
Name [2] 303207 0
The Margaret Walkom Bequest
Country [2] 303207 0
Australia
Funding source category [3] 303208 0
Charities/Societies/Foundations
Name [3] 303208 0
Norman Beischer Medical Research Foundation
Country [3] 303208 0
Australia
Funding source category [4] 303582 0
Hospital
Name [4] 303582 0
Epworth Research
Country [4] 303582 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
Molecular Oncology and Cancer Immunology Department (MOCI)
185-187 Hoddle Street
Richmond
Victoria 3121
Country
Australia
Secondary sponsor category [1] 303218 0
None
Name [1] 303218 0
Address [1] 303218 0
Country [1] 303218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303764 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 303764 0
Ethics committee country [1] 303764 0
Australia
Date submitted for ethics approval [1] 303764 0
05/07/2017
Approval date [1] 303764 0
02/07/2018
Ethics approval number [1] 303764 0
17.20
Ethics committee name [2] 303765 0
Monash Health Human Research Ethics Committee
Ethics committee address [2] 303765 0
Ethics committee country [2] 303765 0
Australia
Date submitted for ethics approval [2] 303765 0
12/02/2019
Approval date [2] 303765 0
14/02/2019
Ethics approval number [2] 303765 0
RES-19-0000107E

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94718 0
Dr Rachel Delahunty
Address 94718 0
Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
Country 94718 0
Australia
Phone 94718 0
+61 3 8559 5000
Fax 94718 0
Email 94718 0
[email protected]
Contact person for public queries
Name 94719 0
Rachel Delahunty
Address 94719 0
Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
Country 94719 0
Australia
Phone 94719 0
+61 3 8559 5000
Fax 94719 0
Email 94719 0
[email protected]
Contact person for scientific queries
Name 94720 0
Rachel Delahunty
Address 94720 0
Victorian Comprehensive Cancer Centre
305 Grattan St, Melbourne VIC 3000
Country 94720 0
Australia
Phone 94720 0
+61 3 8559 5000
Fax 94720 0
Email 94720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.