Clonal Cytopenia of Undetermined Significance, Clonal Hematopoiesis, Idiopathic Cytopenia of Undetermined Significance, Myeloid Neoplasm Post Cytotoxic Therapy, Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder, Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
University of Washington
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through study completion, up to 5 years | Measurement Tool: will measure by BM biopsy confirmation done by local hematologist |
| Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN | Through study completion, up to 5 years | Measurement Tool: the variant allele fraction of the blood clone |
Countries
United States
Contacts
CONTACTSwisher Lab Research Coordinators
PRINCIPAL_INVESTIGATORElizabeth Swisher
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed