Clinical trial NCT05458973: Circulating Tumor DNA and BRCA Reversion Mutation in Advanced or Recurrent Ovarian Cancer Patients With Germline Mutation.
Official title: Circulating Tumor DNA and BRCA Reversion Mutation in Advanced or Recurrent Ovarian Cancer Patients With Germline Mutation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ovarian cancer patients with germline BRCA mutation who receive PARP inhibitor

Brief summary: Increasing number of ovarian cancer patients are receiving PARP inhibitor as maintenance or salvage therapy. Predictive factors to PARP inhibitor other than BRCA mutation or HRD status as well as specific resistance mechanism are unknown. Thus, the objective of this study was to prospectively collect serial blood samples in ovarian cancer patients with germline BRCA mutation who receive PARP inhibitor. We investigated circulating tumor DNA (ctDNA) before patients are started on PARP inhibitor and every 3 months thereafter until progression on PARP inhibitor. Through assessment of the changes in ctDNA mutational landscape, we aimed to investigate resistance mechanism to PARP inhibitor including BRCA reversion mutation.


Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of epithelial ovarian cancer,
2. Presence of germline or somatic BRCA mutation,
3. Patients receiving chemotherapy after primary debulking surgery or interval debulking surgery or patients who are planned to receive chemotherapy after recurrence on first line treatment,
4. Patients with platinum sensitive recurrence (recurrence after 6 months or longer after 1st line treatment) who are planned to receive PARP inhibitor following response to 2nd line chemotherapy.
5. Patients who recurred after 3rd or more lines of chemotherapy and are planned to receive PARP inhibitor.

Exclusion Criteria:

1. Patients who refuse to participate,
2. Patients having difficulty understanding the protocol due to language barrier

Primary outcomes:
measure: identify resistance mechanism after PARPi
timeFrame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years)
Secondary outcomes:
measure: Identify pre-existing genomic profiles that may predict response to PARPi
timeFrame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years)
measure: Identify post-progression resistance mechanisms that may predict response to subsequent therapy
timeFrame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance hospitalYonsei University College of Medicine Department of Obstetrics and Gynecology
name: Jung-Yun Lee
role: PRINCIPAL_INVESTIGATOR
References: