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

Status unconfirmed

Conditions studied: Ovarian Cancer

In brief

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)

Key facts

Study ID

NCT03691012

Run by

Walter and Eliza Hall Institute of Medical Research

People needed

118

Starts

2017-05-09

Expected to finish

2025-05-09

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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