Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Ovarian Cancers (CHANCES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295965
• Other study ID #: RG1123813
• Secondary ID: NCI-2023-10315FH
• Status: Recruiting
• Start date: January 2, 2024
• Est. completion date: December 31, 2031

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: Swisher Lab Research Coordinators
• Phone: 206-616-8927
• Email: swisherlabrc[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian 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.

Description:

OUTLINE: This is an observational study. Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• * Subjects will have or had ovarian cancer and are on or have completed PARPi maintenance therapy
• Or have been diagnosed with ovarian cancer as well as clonal hematopoiesis of indeterminate potential
• Have a life expectancy of greater than 6 months

Exclusion Criteria:

• * Individuals with a life expectancy of less than 6 months

Related Conditions & MeSH terms

• Carcinoma
• Recurrence
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients		Through study completion, up to 5 years
Primary	Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors	Measurement Tool: will measure by BM biopsy confirmation done by local hematologist	Through study completion, up to 5 years
Primary	Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN	Measurement Tool: the variant allele fraction of the blood clone	Through study completion, up to 5 years