ClinicalTrials.gg
RecruitingNCT07675967CH CAREUpdated Jun 30, 2026

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

An observational study in Lung Cancer (Diagnosis), Osteochondroma and Spitz Nevus, sponsored by Dana-Farber Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Dana-Farber Cancer Institute · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Lung Neoplasms by Dana-Farber Cancer Institute — 7 open to participants now, 9 under way, none of them phase 3. Lung Neoplasms · Dana-Farber Cancer Institute.

Started
2025
with 1 other
Observational
6 of 25
3 open now
Registered
25th of 25
by date

Among the 25 studies in Lung Neoplasms by Dana-Farber Cancer Institute, this one is one of 2 that started in 2025, is one of 6 observational ones, and was the 25th registered.

By phase

25 studies; the count open now beside each. This study's row is marked.

No phase10 · 4 open
Observationalthis study6 · 3 open
Phase 26 · 0 open
Phase 12 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 1998; this study’s year is marked. 2 started in 2025.

Size and results

Median enrollment 33 across the 19 interventional studies, 337 across the 6 observational. Of the 15 that completed or were terminated, 6 (40%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 25 studies in Lung Neoplasms by Dana-Farber Cancer Institute, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Lung Cancer (Diagnosis)
  • Osteochondroma
  • Spitz Nevus
  • Solid Cancers
  • Breast Cancer
  • Gastric (Stomach) Cancer
  • Colorectal (Colon or Rectal) Cancer
  • Sarcoma
  • Ovarian Adenocarcinoma
  • Uterine Adenocarcinoma
  • Endometrial Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Head and Neck Cancer
  • Therapy-Related Acute Myeloid Leukemia
  • Therapy-Related MDS
  • Clonal Hematopoiesis of Indeterminate Potential (CHIP)
  • Clonal Cytopenia of Undetermined Significance

Keywords

  • Adult cancer survivors
  • Precursor Lesions
  • clonal hematopoiesis
  • chemotherapy
  • radiation
  • therapy-related myeloid neoplasms
  • CCUS
  • clonal hematopoiesis of indeterminate potential
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants to be included in this study include the following:
  • Adults age >18 years
  • Diagnosed with solid (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.

Exclusion criteria

Exclusion Criteria:

  • Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure
  • Individuals who have received prior chemotherapy and or radiation for their current solid (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    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.

    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.

    Other: Samples

Interventions

  • OtherSamples

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: baseline

  3. 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.

    Time frame: Up to 5 years; assessed at time 0, 6 months, and annually

  4. 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.

    Time frame: Up to 5 years

  5. Overall survival

    Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death.

    Time frame: Up to 5 years

  6. 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.

    Time frame: Up to 5 years

  7. 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.

    Time frame: 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.

    Time frame: Up to 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 40267434 ↗
  • Morganti 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 38190580 ↗
  • Weeks LD, Ebert BL. Causes and consequences of clonal hematopoiesis. Blood. 2023 Dec 28;142(26):2235-2246. doi: 10.1182/blood.2023022222. PubMed 37931207 ↗
  • Weeks 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data can be shared no earlier than 1 year following the date of publication

Access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07675967
Responsible party
Lachelle D. Weeks, MD, PhD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Jun 30, 2026
Start date
Apr 4, 2025
Primary completion
Jun 30, 2028 (estimated)
Completion
Mar 31, 2035 (estimated)
Last update
Jun 30, 2026

Study contacts

Cindy Amaya Lopez, BA
Contact
DFCICHCARESTUDY@DFCI.HARVARD.EDU
857-215-1943
Jenna Beckwith, MPH
Contact
Lachelle D Weeks, MD, PhD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion