Clinical trial NCT06295965: Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Official title: Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)
Study type: OBSERVATIONAL
Overall status: 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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-06
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients
timeFrame: Through study completion, up to 5 years
measure: Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors
timeFrame: Through study completion, up to 5 years
measure: Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN
timeFrame: Through study completion, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Elizabeth Swisher
role: PRINCIPAL_INVESTIGATOR
References: