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

NCT ID: NCT03691012

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2025-05-09

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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Circulating tumour DNA testing

Circulating tumour DNA testing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Walter and Eliza Hall Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Maria Edmonds

Assoc Professor Sumitra Ananda

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sumitra Ananda, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Walter and ELiza Hall Institute

Locations

John Hopkins University School of Medicine

Baltimore, Maryland, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Epworth Freemasons

Melbourne, Victoria, Australia

Western Hospital

Melbourne, Victoria, Australia

Mercy Hospital for Women

Melbourne, Victoria, Australia

Cabrini Malvern

Melbourne, Victoria, Australia

Monash Medical Centre

Melbourne, Victoria, Australia

Countries

United States; Australia

Other Identifiers

WEHI-ctDNA-10

Identifier Type: -

Identifier Source: org_study_id