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

ConditionsRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Malignant Solid NeoplasmClonal Cytopenia of Undetermined SignificanceClonal HematopoiesisIdiopathic Cytopenia of Undetermined SignificanceNon-Neoplastic Hematopoietic and Lymphoid Cell DisorderOvarian CarcinomaMyeloid Neoplasm Post Cytotoxic Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy

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

Disqualifiers

Individuals with a life expectancy of less than 6 months

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, up to 5 years
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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