Ovarian Cancer Clinical Trial
Circulating Tumour DNA as a Marker of Residual Disease & Response to Adjuvant Chemotherapy in Stage I-IV Ovarian Cancer
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)
Full 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.
Eligibility Criteria
Inclusion Criteria:
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.
A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available.
Fit and planned for adjuvant chemotherapy
Exclusion Criteria:
History of another primary cancer within the last 3 years
Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC) of mucinous subtype and sarcoma
Patients with Stage IV disease who have residual disease
Patients <18 years
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There are 7 Locations for this study
Baltimore Maryland, 21287, United States
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3002, Australia
Melbourne Victoria, 3021, Australia
Melbourne Victoria, 3084, Australia
Melbourne Victoria, 3144, Australia
Melbourne Victoria, 3168, Australia
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