Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study

Recruiting

• Conditions: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Malignant Solid Neoplasm; Clonal Cytopenia of Undetermined Significance; Clonal Hematopoiesis; Idiopathic Cytopenia of Undetermined Significance; Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder; Ovarian Carcinoma; Myeloid Neoplasm Post Cytotoxic Therapy
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06295965
• Lead Sponsor: University of Washington

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.

Detailed Description

OUTLINE: This is an observational study.

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

Study Timeline

• Study Start: 2024-01-02
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2028-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States