- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06295965
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
April 14, 2026 updated by: University of Washington
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)
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.
Study Overview
Status
Recruiting
Conditions
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Malignant Solid Neoplasm
- Ovarian Carcinoma
- Clonal Cytopenia of Undetermined Significance
- Clonal Hematopoiesis
- Idiopathic Cytopenia of Undetermined Significance
- Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder
- Myeloid Neoplasm Post Cytotoxic Therapy
Intervention / Treatment
Detailed Description
OUTLINE: This is an observational study.
Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Swisher Lab Research Coordinators
- Phone Number: 206-616-8927
- Email: swisherlabrc@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutch/University of Washington Cancer Consortium
-
Principal Investigator:
- Elizabeth Swisher
-
Contact:
- Swisher Lab Research Coordinators
- Phone Number: 206-616-8927
- Email: swisherlabrc@uw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
Patients undergo blood sample collection and complete surveys on study.
Patients' medical records are also reviewed.
|
Non-interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients
Time Frame: Through study completion, up to 5 years
|
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
|
Measurement Tool: will measure by BM biopsy confirmation done by local hematologist
|
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
|
Measurement Tool: the variant allele fraction of the blood clone
|
Through study completion, up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Swisher, Fred Hutch/University of Washington Cancer Consortium
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2031
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 28, 2024
First Posted (Actual)
March 6, 2024
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
Other Study ID Numbers
- RG1123813
- NCI-2023-10315 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- FHIRB0020162 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- R01CA272594 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Fallopian Tube Carcinoma
-
Mayo ClinicRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Seromucinous Carcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Ovarian High Grade Serous Adenocarcinoma | Fallopian... and other conditionsUnited States, Puerto Rico
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingOvarian Seromucinous Carcinoma | Recurrent Ovarian High Grade Serous Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Fallopian Tube Mucinous Adenocarcinoma | Recurrent Fallopian Tube Clear Cell Adenocarcinoma | Recurrent Fallopian Tube Endometrioid Adenocarcinoma | Recurrent... and other conditionsUnited States, Puerto Rico
-
Roswell Park Cancer InstituteCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Tumor | Fallopian Tube Endometrioid Tumor | Ovarian Endometrioid Tumor | Fallopian Tube Mucinous Neoplasm | Fallopian Tube Serous Neoplasm | Ovarian Serous Tumor | Ovarian Mucinous...United States
-
National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Primary Peritoneal Carcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Malignant Ovarian Endometrioid Tumor | Ovarian High Grade Serous Adenocarcinoma | Platinum-Sensitive Ovarian Carcinoma | Fallopian Tube High Grade Serous Adenocarcinoma and other conditionsUnited States
-
National Cancer Institute (NCI)WithdrawnRecurrent Ovarian High Grade Serous Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Recurrent Fallopian Tube Clear Cell Adenocarcinoma | Recurrent Fallopian Tube Undifferentiated Carcinoma | Recurrent Ovarian Clear Cell Adenocarcinoma | Recurrent Ovarian Undifferentiated Carcinoma and other conditions
-
National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Undifferentiated Carcinoma | Ovarian Clear Cell Adenocarcinoma | Ovarian Mucinous Adenocarcinoma | Fallopian Tube... and other conditionsUnited States
Clinical Trials on Non-Interventional Study
-
Ohio State University Comprehensive Cancer CenterCompletedHeavy Metal Exposure From VapingUnited States
-
Portsmouth Hospitals NHS TrustArdia Digital Health LtdNot yet recruitingChronic Kidney Disease
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI)RecruitingProstate CarcinomaUnited States
-
Mayo ClinicRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphatic System NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterLilly FoundationRecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Advanced Breast Carcinoma | Metastatic Breast CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Enrolling by invitationBarrett Esophagus | Esophageal AdenocarcinomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Merck Sharp & Dohme LLCRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphatic System NeoplasmUnited States
-
Roswell Park Cancer InstituteRecruitingCigarette Smoking-Related CarcinomaUnited States
-
Children's Oncology GroupNot yet recruitingChildhood Hematopoietic and Lymphatic System Neoplasm | Childhood Malignant Solid Neoplasm
-
Ohio State University Comprehensive Cancer CenterAmerican Association for Cancer ResearchRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Breast Carcinoma | Hormone Receptor-Positive Breast CarcinomaUnited States