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

NCT03691012 | Unknown DMC

• 1 other identifier: WEHI-ctDNA-10
• Study Type: observational
• Target: 118
• Locations: 2 countries
• Sites: 7

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)

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells,can be used as highly specific biomarkers of disease burden. Baseline.

  polymerase chain reaction (PCR) to quantify ctDNA

  After surgery (primary debulking group) or pre cycle 1 of therapy (neoadjuvant) confirmed with conventional radiological imaging and CA125 (cycles of chemotherapy are 21 days in length).

Secondary Outcomes (5)

• Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.

  At the completion of pre cycle 3 of chemotherapy (primary debulking group) confirmed with Convential Radiological imaging and CA125. (each cycle 21 days in length)

• Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.

  circulating tumour DNA (ctDNA) during chemotherapy pre cycle 5 confirmed (primary debluking group) with conventional Radiological imaging and CA125 (each cycle 21 days in length).

• Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result

  circulating tumour DNA (ctDNA) during chemotherapy pre cycle 3 or 4 (neoadjuvant group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)

• Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.

  At the completion of 6 of chemotherapy (primary debulking group) confirmed with conventional Radiological imaging and CA125 (each cycle 21 days in length)

• Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.

  At the completion of 6 cycles of chemotherapy (neoadjuvant group) confirmed with conventional radiology and CA125 (at the end of 18 weeks).

Interventions

Circulating tumour DNA testing DIAGNOSTIC_TEST

Circulating tumour DNA testing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Ovarian Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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

Sponsors & Collaborators

• Walter and Eliza Hall Institute of Medical Research: lead
• Johns Hopkins University: collaborator

Study Sites (7)

John Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Epworth Freemasons

Melbourne, Victoria, 3002, Australia

Location

Western Hospital

Melbourne, Victoria, 3021, Australia

Location

Mercy Hospital for Women

Melbourne, Victoria, 3084, Australia

Location

Cabrini Malvern

Melbourne, Victoria, 3144, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Using the Safe-SeqS assay, the fraction of total DNA fragments (mutant and wild-type) of a given gene that contains the queried mutation will be determined. In cases where mutations are acquired in the tumour, mutant DNA fragments are expected to represent only a small fraction of the total DNA fragments in the circulation. In cases with germline BRCA mutations, where normal or non-tumour cells also harbour the specific DNA changes, we would expect to find the fraction of mutant DNA for a given gene to be much higher. If unexpected results are found for mutations, indicating the possibility of an inherited mutation, the patient will be informed of the result by their treating doctor and the potential implication.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sumitra Ananda, Associate Professor

  Walter and ELiza Hall Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor Sumitra Ananda

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: October 1, 2018
• Study Start: May 9, 2017
• Primary Completion: December 31, 2020
• Study Completion: May 9, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (6)