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

NCT06295965 | Recruiting

• 4 other identifiers: RG1123813NCI-2023-10315FHIRB0020162R01CA272594
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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; Clonal Hematopoiesis; Idiopathic Cytopenia of Undetermined Significance; Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder; Ovarian Carcinoma; Myeloid Neoplasm Post Cytotoxic Therapy

Outcome Measures

Primary Outcomes (3)

• Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients

  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

  Measurement Tool: will measure by BM biopsy confirmation done by local hematologist

  Through study completion, up to 5 years

• 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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have had ovarian, peritoneal, or fallopian tube cancer and have completed or plan to complete at least 5 cycles of platinum-based chemotherapy or subjects who have had a solid tumor diagnosis and have received at least 4 months of PARP inhibitor and/or been diagnosed with a blood disorder.

You may qualify if:

• 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
• 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

You may not qualify if:

• Individuals with a life expectancy of less than 6 months

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Elizabeth Swisher

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Swisher Lab Research Coordinators

CONTACT

206-616-8927; swisherlabrc@uw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 6, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)