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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:10/3/2018
Start Date:May 9, 2017
End Date:May 9, 2023
Contact:Maria Edmonds, Master
Email:Maria.Edmonds@mh.org.au
Phone:61393452896

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Circulating Tumour DNA as a Marker of Residual Disease and Response to Adjuvant Chemotherapy in Stage I-IV Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC)

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)

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.

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
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Melbourne, Victoria 3004
Phone: 61393452896
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Baltimore, Maryland 21287
Phone: 410-955-5800
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