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Can a simple blood test predict leukemia risk after cancer therapy?

NCT ID NCT07675967

Knowledge-focused Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study investigates clonal hematopoiesis (CH) — small mutations in blood cells that can arise naturally or after cancer treatment — in adults receiving chemotherapy or radiation for solid tumors like breast, lung, or colorectal cancer. Researchers will collect blood, saliva, urine, stool, and tissue samples from 5,000 participants before and during therapy to track how CH changes over time. The goal is to build a tool that predicts who is at highest risk for developing therapy-related myeloid neoplasms (t-MNs), a serious blood cancer, and ultimately find ways to prevent it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could lead to a risk prediction algorithm that identifies patients most likely to develop therapy-related leukemia, potentially guiding preventive strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient care, and the findings might not apply to all cancer types or treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Mar 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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 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.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus breast cancer breast neoplasm cancer clonal hematopoiesis of indeterminate potential colonic neoplasm colorectal cancer disease endometrium adenocarcinoma esophageal adenocarcinoma esophageal cancer gastric cancer gastric neoplasm head and neck cancer Head and Neck Neoplasms lung cancer lung neoplasm mixed epithelioid and spindle cell melanoma Osteochondroma ovarian adenocarcinoma ovarian cancer sarcoma spitz nevus therapy-related myeloid neoplasm uterine cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Clonal cytopenia of undetermined significance Clonal hematopoiesis of indeterminate potential (CHIP) Colorectal (colon or rectal) cancer Endometrial adenocarcinoma Esophageal adenocarcinoma Gastric (stomach) cancer Head and neck cancer Lung cancer (diagnosis) Osteochondroma Ovarian adenocarcinoma Sarcoma Solid cancers Spitz nevus Therapy-related acute myeloid leukemia Therapy-related MDS Uterine adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.