The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Circulating Tumor DNA and BRCA Reversion Mutation in Advanced or Recurrent Ovarian Cancer Patients With Germline Mutation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05458973
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date July 5, 2022
First Posted Date July 14, 2022
Last Update Posted Date September 13, 2022
Actual Study Start Date October 31, 2017
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2022)		 identify resistance mechanism after PARPi [ Time Frame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years) ]
Investigators will utilize baseline and post-progression samples to identify PARP resistance mechanism for each patient. For patients without baseline blood sample prior to PARP inhibitor usage, tumor Next Generation Sequencing results will be utilized. After identification of newly acquired mutations after PARP inhibitor use, these genes then will be classified into resistance mechanism category. Patients will undergo standard clinical surveillance, which will be based on serum CA125 and radiological assessment every 3 months interval; whole blood for ctDNA will also be collected at every 3 months interval. Upon progression based on clinical surveillance (which usually ranges from 6 months to 2 years), the corresponding whole blood-based ctDNA sample can be used as post-progression sample. The post-progression sample can then be compared with the baseline sample to inform PARP resistance mechanism.
Original Primary Outcome Measures
 (submitted: July 13, 2022)		 Exploration of PARP resistance mechanism [ Time Frame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years) ]
Investigators will utilize baseline and post-progression samples to identify PARP resistance mechanism for each patient. For patients without baseline blood sample prior to PARP inhibitor usage, tumor Next Generation Sequencing results will be utilized. After identification of newly acquired mutations after PARP inhibitor use, these genes then will be classified into resistance mechanism category. Patients will undergo standard clinical surveillance, which will be based on serum CA125 and radiological assessment every 3 months interval; whole blood for ctDNA will also be collected at every 3 months interval. Upon progression based on clinical surveillance (which usually ranges from 6 months to 2 years), the corresponding whole blood-based ctDNA sample can be used as post-progression sample. The post-progression sample can then be compared with the baseline sample to inform PARP resistance mechanism.
Change History
Current Secondary Outcome Measures
 (submitted: September 7, 2022)
  • Identify pre-existing genomic profiles that may predict response to PARPi [ Time Frame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years) ]
    Investigators will utilize baseline blood samples to identify pre-existing genomic profiles that may predict response to PARPi. Post progression blood samples will be used to identify post-specific mechanisms that may predict response to subsequent therapy.
  • Identify post-progression resistance mechanisms that may predict response to subsequent therapy [ Time Frame: every 3 months interval until progression based on clinical surveillance (which usually ranges from 6 months to 2 years) ]
    Investigators will utilize baseline blood samples to identify pre-existing genomic profiles that may predict response to PARPi. Post progression blood samples will be used to identify post-specific mechanisms that may predict response to subsequent therapy. Time frame for measurement of secondary outcome will be the same as the time frame for primary outcome. Clinical profiles such as progression-free survival with respect to PARPi, progression-free survival to post-progression subsequent therapy, and overall survival will be utilized.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Circulating tumor DNA based on whole blood. The investigator will peripheral blood from ovarian cancer patients receiving PARP inhibitor for every three months until progression.
Sampling Method Non-Probability Sample
Study Population Ovarian cancer patients with germline BRCA mutation who receive PARP inhibitor
Condition Ovarian Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Frontline cohort
  • recurrent cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2022)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jung-Yun Lee 822-2228-2237 jungyunlee@yuhs.ac
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT05458973
Other Study ID Numbers 4-2017-0851
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor Yonsei University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jung-Yun Lee Severance hospitalYonsei University College of Medicine Department of Obstetrics and Gynecology
PRS Account Yonsei University
Verification Date September 2022