Lung Cancer (Diagnosis)CH CARENCT07675967
Clonal Hematopoiesis Chemotherapy and Radiation Effects Study
An observational study of Lung Cancer (Diagnosis) and Osteochondroma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers. The study will collect biospecimens and clinical information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Osteochondroma, Spitz Nevus
- What is being tested?
- Samples
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2025to 31 Mar 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants to be included in this study include patients who have a diagnosis of solid cancer for which they are planning to receive cytotoxic chemotherapy, radiation, or PARP inhibitor therapy.
Who may be able to join
- Participants to be included in this study include the following:
- Adults age >18 years
- Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)
- Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).
- Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.
Who cannot join
- Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure
- Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)
- Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jenna Beckwith, MPH contact
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers.
The study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs).
Ultimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.
Read the detailed description
The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation.
Blood, buccal swabs, or other body fluids may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes. These materials will be collected from all eligible participants. It is expected that about 5,000 people will take part in this research study.
- Conditions
- Lung Cancer (Diagnosis), Osteochondroma, Spitz Nevus, Solid Cancers, Breast Cancer, Gastric (Stomach) Cancer
- Being tested
- Samples
- Keywords
- Adult cancer survivors, Precursor Lesions, clonal hematopoiesis, chemotherapy, radiation, therapy-related myeloid neoplasms, CCUS, clonal hematopoiesis of indeterminate potential
- Medical subject headings
- Lung Neoplasms, Disease, Osteochondroma, Nevus, Epithelioid and Spindle Cell, Breast Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues
| Study group | Role | What they receive |
|---|---|---|
| HEREDITARY RISK | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. Receives: Other: Samples | |
| EXPOSED HIGH RISK | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. Receives: Other: Samples | |
| PRECURSOR LESIONS | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of clonal hematopoiesis
Prevalence of clonal hematopoiesis detected by the study's targeted unique molecular identifier-based sequencing panel in population of adults with advanced non-metastatic solid cancers.
Measured: Baseline
Gene distribution of clonal hematopoiesis
Distribution of genes mutated among subpopulation with clonal hematopoiesis in population of adults receiving chemotherapy and radiation therapy for solid malignancy.
Measured: baseline
Change in clonal hematopoiesis variant allele fraction
Change in clonal hematopoiesis allelic fractions over follow-up in patients receiving chemotherapy and radiation for advanced non-metastatic solid malignancy, based on serial sequencing of stored blood specimens.
Measured: Up to 5 years; assessed at time 0, 6 months, and annually
Solid malignancy progression
Solid malignancy progression in relation to the presence of clonal hematopoiesis, based on clinical progression data abstracted from the electronic health record and follow-up data collected under protocol 22-200.
Measured: Up to 5 years
Overall survival
Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death.
Measured: Up to 5 years
Development of hematologic toxicity
Development of hematologic toxicity in relation to the presence of clonal hematopoiesis, using abstracted clinical and laboratory data, including CBC values and related treatment information.
Measured: Up to 5 years
Development of therapy-related myeloid neoplasm (t-MN)
Development of therapy-related myeloid neoplasm in relation to the presence of clonal hematopoiesis, using abstracted dates of diagnosis of hematologic malignancies and related follow-up data.
Measured: Up to 10 years
Secondary outcomes (1)
Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis
Aggregate study data will be utilized to identify features most predictive of adverse clonal hematopoiesis-related outcomes in patients receiving chemotherapy and/or radiation for solid malignancies. These features will be combined into the development of a predictive algorithm that is capable of identifying patient populations at-risk for t-MN.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start4 Apr 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lachelle D. Weeks, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Lachelle D Weeks, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675967
- Sponsor's protocol ID
- 24-431
- Acronym
- CH CARE
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Weeks LD, Ebert BL. Clonal Hematopoiesis as a Driver of Solid Tumors. N Engl J Med. 2025 Apr 24;392(16):1654-1656. doi: 10.1056/NEJMe2504775. No abstract available.
PubMed 40267434Morganti S, Gibson CJ, Jin Q, Santos K, Patel A, Wilson A, Merrill M, Vincuilla J, Stokes S, Lipsyc-Sharf M, Parker T, King TA, Mittendorf EA, Curigliano G, Hughes ME, Stover DG, Tolaney SM, Weeks LD, Tayob N, Lin NU, Garber JE, Miller PG, Parsons HA. Prevalence, Dynamics, and Prognostic Role of Clonal Hematopoiesis of Indeterminate Potential in Patients With Breast Cancer. J Clin Oncol. 2024 Nov;42(31):3666-3679. doi: 10.1200/JCO.23.01071. Epub 2024 Jan 8.
PubMed 38190580Weeks LD, Ebert BL. Causes and consequences of clonal hematopoiesis. Blood. 2023 Dec 28;142(26):2235-2246. doi: 10.1182/blood.2023022222.
PubMed 37931207Weeks LD, Niroula A, Neuberg D, Wong W, Lindsley RC, Luskin M, Berliner N, Stone RM, DeAngelo DJ, Soiffer R, Uddin MM, Griffin G, Vlasschaert C, Gibson CJ, Jaiswal S, Bick AG, Malcovati L, Natarajan P, Ebert BL. Prediction of risk for myeloid malignancy in clonal hematopoiesis. NEJM Evid. 2023 May;2(5):10.1056/evidoa2200310. doi: 10.1056/evidoa2200310. Epub 2023 Apr 25.
PubMed 37483562
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Hematopoiesis Chemotherapy and Radiation Effects Study
- ClinicalTrials.gov ID
- NCT07675967
- Acronym / sponsor ID
- CH CARE / 24-431
- Conditions
- Lung Cancer (Diagnosis), Osteochondroma, Spitz Nevus, Solid Cancers, Breast Cancer, Gastric (Stomach) Cancer
- Keywords
- Adult cancer survivors, Precursor Lesions, clonal hematopoiesis, chemotherapy, radiation, therapy-related myeloid neoplasms, CCUS, clonal hematopoiesis of indeterminate potential
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Mar 2035 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers.
The study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs).
Ultimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.
Detailed description
The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation.
Blood, buccal swabs, or other body fluids may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes. These materials will be collected from all eligible participants. It is expected that about 5,000 people will take part in this research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEREDITARY RISK | – | Other: SamplesParticipants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. |
| EXPOSED HIGH RISK | – | Other: SamplesParticipants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. |
| PRECURSOR LESIONS | – | Other: SamplesParticipants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants to be included in this study include patients who have a diagnosis of solid cancer for which they are planning to receive cytotoxic chemotherapy, radiation, or PARP inhibitor therapy.
Key inclusion criteria (5 listed)
- Participants to be included in this study include the following:
- Adults age >18 years
- Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)
- Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).
- Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.
Key exclusion criteria (3 listed)
- Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure
- Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)
- Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplesTissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues | Other | EXPOSED HIGH RISK, HEREDITARY RISK, PRECURSOR LESIONS |
Primary outcome
Prevalence of clonal hematopoiesis
Time frame: Baseline
Prevalence of clonal hematopoiesis detected by the study's targeted unique molecular identifier-based sequencing panel in population of adults with advanced non-metastatic solid cancers.
Gene distribution of clonal hematopoiesis
Time frame: baseline
Distribution of genes mutated among subpopulation with clonal hematopoiesis in population of adults receiving chemotherapy and radiation therapy for solid malignancy.
Change in clonal hematopoiesis variant allele fraction
Time frame: Up to 5 years; assessed at time 0, 6 months, and annually
Change in clonal hematopoiesis allelic fractions over follow-up in patients receiving chemotherapy and radiation for advanced non-metastatic solid malignancy, based on serial sequencing of stored blood specimens.
Solid malignancy progression
Time frame: Up to 5 years
Solid malignancy progression in relation to the presence of clonal hematopoiesis, based on clinical progression data abstracted from the electronic health record and follow-up data collected under protocol 22-200.
Overall survival
Time frame: Up to 5 years
Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death.
Development of hematologic toxicity
Time frame: Up to 5 years
Development of hematologic toxicity in relation to the presence of clonal hematopoiesis, using abstracted clinical and laboratory data, including CBC values and related treatment information.
Development of therapy-related myeloid neoplasm (t-MN)
Time frame: Up to 10 years
Development of therapy-related myeloid neoplasm in relation to the presence of clonal hematopoiesis, using abstracted dates of diagnosis of hematologic malignancies and related follow-up data.
1 secondary outcome
Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 40267434Weeks LD, Ebert BL. Clonal Hematopoiesis as a Driver of Solid Tumors. N Engl J Med. 2025 Apr 24;392(16):1654-1656. doi: 10.1056/NEJMe2504775. No abstract available.
- Background: PubMed 38190580Morganti S, Gibson CJ, Jin Q, Santos K, Patel A, Wilson A, Merrill M, Vincuilla J, Stokes S, Lipsyc-Sharf M, Parker T, King TA, Mittendorf EA, Curigliano G, Hughes ME, Stover DG, Tolaney SM, Weeks LD, Tayob N, Lin NU, Garber JE, Miller PG, Parsons HA. Prevalence, Dynamics, and Prognostic Role of Clonal Hematopoiesis of Indeterminate Potential in Patients With Breast Cancer. J Clin Oncol. 2024 Nov;42(31):3666-3679. doi: 10.1200/JCO.23.01071. Epub 2024 Jan 8.
- Background: PubMed 37931207Weeks LD, Ebert BL. Causes and consequences of clonal hematopoiesis. Blood. 2023 Dec 28;142(26):2235-2246. doi: 10.1182/blood.2023022222.
- Background: PubMed 37483562Weeks LD, Niroula A, Neuberg D, Wong W, Lindsley RC, Luskin M, Berliner N, Stone RM, DeAngelo DJ, Soiffer R, Uddin MM, Griffin G, Vlasschaert C, Gibson CJ, Jaiswal S, Bick AG, Malcovati L, Natarajan P, Ebert BL. Prediction of risk for myeloid malignancy in clonal hematopoiesis. NEJM Evid. 2023 May;2(5):10.1056/evidoa2200310. doi: 10.1056/evidoa2200310. Epub 2023 Apr 25.
- Individual participant dataSharing planned: Yes. The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenna Beckwith, MPH contact
Lachelle D Weeks, MD, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Osteochondroma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cindy Amaya Lopez, BA (857-215-1943, DFCICHCARESTUDY@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of clonal hematopoiesis (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675967, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.