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Recruiting NCT06295965

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

— Observational Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Malignant Solid Neoplasm. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

OUTLINE: This is an observational study.

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

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • 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 [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 [Time frame: Through study completion, up to 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT06295965 · RG1123813 · NCI-2023-10315 · FHIRB0020162 · R01CA272594

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗