Circulating Tumour DNA as a Marker of Residual Disease & Response to Adjuvant Chemotherapy in Stage I-IV Ovarian Cancer

Active, not recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT03691012
• Lead Sponsor: Walter and Eliza Hall Institute of Medical Research

Brief Summary

To demonstrate that detectable ctDNA in peripheral blood following debulking of the primary tumour or following completion of adjuvant treatment for is associated with subsequent disease recurrence in stage I-IV epithelial, fallopian tube and primary peritoneal cancer (Ovarian Cancer)

Detailed Description

This is a prospective,multi-centre study involving serial blood collections from 100 stage I-IV debulked (or to be debulked in the case of neoadjuvant chemotherapy) high grade serous, endometrioid and clear cell ovarian, fallopian tube and primary peritoneal cancer patients (EOC) or ovarian carcinosarcoma planned to receive adjuvant chemotherapy. Tumour samples will be made available following patient enrollment for the primary debulking group, and following surgery for the neoadjuvant group for mutation analysis. Ascites will not be accepted. Up to four blood samples in the primary debulking group and up to five blood samples in the neoadjuvant group will be collected from each patient over a 6-8 month period for ctDNA and Ca125 analysis Choice of chemotherapy will be platinum based treatment at the treating clinician's discretion as per standard of care.

Study Timeline

• Study Start: 2017-05-09
• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Primary Completion: 2020-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Study Completion: 2025-05-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

1. Patients that have had primary debulking surgery for curatively resected stage I-IV high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Stage IV patients can only be included in the study if they have had a complete resection of all macroscopic disease with no residual disease.

   OR Patients commencing neoadjuvant chemotherapy for stage I- III high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Women must be planned to undergo interim debulking surgery.

2. A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available.

3. Fit and planned for adjuvant chemotherapy

Exclusion Criteria

1. History of another primary cancer within the last 3 years
2. Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC) of mucinous subtype and sarcoma
3. Patients with Stage IV disease who have residual disease
4. Patients <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells,can be used as highly specific biomarkers of disease burden. Baseline.	After surgery (primary debulking group) or pre cycle 1 of therapy (neoadjuvant) confirmed with conventional radiological imaging and CA125 (cycles of chemotherapy are 21 days in length).	polymerase chain reaction (PCR) to quantify ctDNA

Secondary Outcome Measures

Name	Time	Method
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.	At the completion of 6 cycles of chemotherapy (neoadjuvant group) confirmed with conventional radiology and CA125 (at the end of 18 weeks).	polymerase chain reaction (PCR) to quantify ctDNA
Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result	circulating tumour DNA (ctDNA) during chemotherapy pre cycle 3 or 4 (neoadjuvant group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)	polymerase chain reaction (PCR) to quantify ctDNA

Trial Locations

Locations (7)

John Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Western Hospital; 🇦🇺 Melbourne, Victoria, Australia

Mercy Hospital for Women; 🇦🇺 Melbourne, Victoria, Australia

Cabrini Malvern; 🇦🇺 Melbourne, Victoria, Australia

Epworth Freemasons; 🇦🇺 Melbourne, Victoria, Australia

Monash Medical Centre; 🇦🇺 Melbourne, Victoria, Australia