None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate whether the presence of circulating tumour DNA (ctDNA) in a patient's blood following surgery or chemotherapy for ovarian cancer, is associated with cancer recurrence. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have stage I-IV curatively resected high grade serous, endometrioid and clear cell ovarian, fallopian tube or primary peritoneal cancer or ovarian carcinosarcoma for which you are scheduled to commence neoadjuvant or adjuvant chemotherapy. All patients enrolled in this study will have up to five blood samples collected over 6-8 months, followed by a clinical follow up every 3 months for 2 years following completion of chemotherapy. Your treating clinician may also decide to continue with further follow-up. It is hoped that the findings from this trial will demonstrate an association between ctDNA detection in the patients blood following surgery and chemotherapy, with ovarian cancer recurrence. This would allow real-time testing of the benefit of adjuvant chemotherapy by assessing ctDNA.
Interventions
Study involves serial blood collections in patients with stage I-IV epithelial or carcinosarcoma ovarian cancer who have undergone surgery (or will have interim debulking in the case of neoadjuvant chemotherapy) and are planned to receive adjuvant chemotherapy. Four to five blood samples will be collected from each patient over a 6-8 month period for circulating tumour DNA (ctDNA) and Ca125 analysis. Following completion of chemotherapy the patient will be followed up every three months with bl
Study involves serial blood collections in patients with stage I-IV epithelial or carcinosarcoma ovarian cancer who have undergone surgery (or will have interim debulking in the case of neoadjuvant chemotherapy) and are planned to receive adjuvant chemotherapy. Four to five blood samples will be collected from each patient over a 6-8 month period for circulating tumour DNA (ctDNA) and Ca125 analysis. Following completion of chemotherapy the patient will be followed up every three months with blood test for Ca125 for the first two years then followed as per clinician's discretion for survival information.
Sponsors
Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix and fully resected stage1a endometrial cancer 2. Patients with EOC of mucinous subtype and sarcoma 3. Patients with Stage IV disease who have residual disease 4. Patients <18 years
Outcome results
None listed