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

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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

Study Description
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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.

Condition or disease
Ovarian Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Tumor DNA and BRCA Reversion Mutation in Advanced or Recurrent Ovarian Cancer Patients With Germline Mutation.
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Group/Cohort
Frontline cohort
recurrent cohort


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ovarian cancer patients with germline BRCA mutation who receive PARP inhibitor
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05458973


Contacts
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Contact: Jung-Yun Lee 822-2228-2237 jungyunlee@yuhs.ac

Locations
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Korea, Republic of
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jung-Yun Lee    822-2228-2237    jungyunlee@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jung-Yun Lee Severance hospitalYonsei University College of Medicine Department of Obstetrics and Gynecology
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT05458973    
Other Study ID Numbers: 4-2017-0851
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type