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NCT Number: NCT06295965

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

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.

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Key information

Conditions

Recurrent Fallopian Tube Carcinoma Adnexal Diseases Clonal Cytopenia of Undetermined Significance Clonal Hematopoiesis Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Idiopathic Cytopenia of Undetermined Significance Myeloid Neoplasm Post Cytotoxic Therapy Neoplasms Neoplasms by Site Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Recurrent Malignant Solid Neoplasm Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location status: Recruiting

Location contact

Elizabeth Swisher

PRINCIPAL_INVESTIGATOR

Swisher Lab Research Coordinators

CONTACT

[email protected]

206-616-8927

About this study

OUTLINE: This is an observational study.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

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

    Time frame: Through study completion, up to 5 years

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

  3. 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

    Measurement Tool: the variant allele fraction of the blood clone

Study contacts

Contact information is provided by the study sponsor or research team.

Swisher Lab Research Coordinators

CONTACT

[email protected]

206-616-8927

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Mar 6, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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