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New treatment option for Clonal Hematopoiesis
Official title A Dietary Study for People With Clonal Hematopoiesis
ClinicalTrials.gov ID: NCT07590804
What this study is testing
- What it's testing
- The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH. A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample
- Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.
- Variant allele frequency must be ≥2% for mutation as measured by (NGS)
- Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care...
- Age ≥ 18 years
You likely can't join if
- Prior MDS/AML directed therapy
- Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer on observation is eligible)
- Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.
- Concurrent pregnancy will make a participant ineligible to participate
- Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or...
- Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently...
See the full eligibility criteria
- Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample
- Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.
- Variant allele frequency must be ≥2% for mutation as measured by (NGS)
- Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this...
- Age ≥ 18 years
- BMI ≥25 kg/m\^2
- Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking.
- Screening 24-hour dietary recall must consume \<30 grams dietary fiber per day to be eligible (any one of two 24-hour screening dietary recalls).
- For patients at MSK, require bone marrow biopsy at screening in the past 24 weeks with collection of research biobanking sample. Bone marrow at other sites is optional.
- Prior MDS/AML directed therapy
- Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer on observation is eligible)
- Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.
- Concurrent pregnancy will make a participant ineligible to participate
- Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).
- Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently for diabetes mellitus control but not weight loss they are eligible...
- Mental impairment leading to inability to cooperate will lead to exclusion from trial participation.
- If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.
- Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.
- Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.
- Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.
- Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.