Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT06295965

Conditions

Recurrent Fallopian Tube Carcinoma

Recurrent Ovarian Carcinoma

Recurrent Primary Peritoneal Carcinoma

Recurrent Malignant Solid Neoplasm

Clonal Cytopenia of Undetermined Significance

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.

Conditions

Recurrent Fallopian Tube Carcinoma

Recurrent Ovarian Carcinoma

Recurrent Primary Peritoneal Carcinoma

Recurrent Malignant Solid Neoplasm

Clonal Cytopenia of Undetermined Significance

Study ID

NCT06295965

Start date

Jan 2, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:

  • Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy

OR

  • Subjects who have or have had a solid tumor diagnosis and any of the following:

  • At least 4 months of exposure to a PARP inhibitor
  • Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm

Exclusion Criteria:

  • Individuals with a life expectancy of less than 6 months

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients [ Time Frame: Through study completion, up to 5 years ]
  • Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors [ Time Frame: Through study completion, up to 5 years ]
  • Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN [ Time Frame: Through study completion, up to 5 years ]

Central Contacts and Locations

Central contacts

Swisher Lab Research Coordinators

206-616-8927swisherlabrc@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Swisher Lab Research Coordinators

206-616-8927swisherlabrc@uw.edu

Principal Investigator:

Elizabeth Swisher

More Information

Sponsor

University of Washington

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-04-17.