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

University of Washington2,000 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Malignant Solid Neoplasm Clonal Cytopenia of Undetermined Significance Clonal Hematopoiesis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

Measurement Tool: the variant allele fraction of the blood clone

Time frame: Through study completion, up to 5 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts