NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult Myelodysplastic Syndromes (MDS)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000661-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Fetuses

Keywords

Heterogenous Stem Cell Disorders;
Gene Mutations;
Dysplasia;
cytopenias;
Malignancies;
Acute Myeloid Leukemia;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Myelodysplastic Syndromes

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

Myelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal. There are limited treatment options for MDS. Researchers want to learn more through this natural history study so they can develop better treatments.

Objective:

To study the natural course of MDS and MDS/myeloproliferative neoplasms (MPN) and collect biological samples that can help researchers understand the disease.

Eligibility:

People with suspected or confirmed MDS or MDS/MPN. Healthy donors are also needed. They can be people who are scheduled to donate bone marrow at NIH for a relative, or they may be providing bone marrow in another study.

Design:

Participants will be screened with a medical history.

Participants will have a physical exam. They will give blood and urine samples. They will discuss their symptoms, medications, and ability to perform their normal activities. They will complete surveys about how they are feeling.

Participants will have a bone marrow biopsy. A needle will be inserted through a small cut. Bone marrow will be removed. A small piece of bone may be removed.

Participants may have an optional skin biopsy.

Participants may give optional saliva and stool samples. They may collect these samples at home and mail them to NIH.

Participants may undergo optional apheresis. One or two needles or intravenous (IV) lines will be placed in their arm, neck, or groin veins. Blood will be removed. A machine will separate out the white cells. The rest of the blood will be returned to the participant.

Participants will be contacted for follow-up once a year for up to 20 years.

Healthy donors will have marrow collected for this study during their scheduled procedure with no follow-up.

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Eligibility

INCLUSION CRITERIA - MDS Participants

- Any gender, any age.

- Histologically or cytologically suspected or confirmed myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN), MDS/myeloproliferative neoplasm with ringed sideroblasts and thrombocytosis (MDS/MPN-RS-T), myelodysplastic syndromes/myeloproliferative neoplasms unclassified (MDS/MPN-U), chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), secondary acute myeloid leukemia (sAML) with antecedent MDS or MDS/MPN, or participants who have precursor conditions that are associated with a risk of progression to MDS, including but not limited to clonal hematopoiesis of indeterminate potential (CHIP) and clonal cytopenia of unknown significance (CCUS).

- Participants may have had any amount of prior therapy and may be receiving MDS-directed therapy at time of enrollment.

- Participants must have an identified primary oncologist, hematologist or generalist outside of NIH who agrees to manage participant care and any diagnostic findings provided by this study.

INCLUSION CRITERIA - Marrow Control Donor Participants

- Any gender, and must be eligible for marrow donation per NIH Clinical Center requirements.

- No history of hematological malignancies as listed as inclusion in 'Inclusion Criteria - MDS Participants' or current autoimmune disease.

- Must be scheduled for bone marrow harvest for clinical application (e.g., marrow donation); or, if being evaluated for malignancy, have a clinical bone marrow aspirate scheduled (e.g., to rule out bone marrow involvement).

INCLUSION CRITERIA - All Participants

- Stated willingness to comply with all study procedures and availability for the duration of the study.

- Ability of participant or parent/guardian to understand and the willingness to sign a written consent document.

EXCLUSION CRITERIA - All Participants

-Uncontrolled intercurrent illness, psychiatric illness, or other that would limit compliance with study requirements, or at the investigator s discretion.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kathy McGraw, Ph.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 41
Room B622
41 Center Drive
Bethesda, Maryland 20892
(240) 760-7134
kathy.mcgraw@nih.gov

Rebecca Alexander
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4-3152
10 Center Drive
Bethesda, Maryland 20892
(240) 781-4037
rebecca.alexander@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT05350748

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult Myelodysplastic Syndromes (MDS)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000661-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Fetuses

Keywords

Heterogenous Stem Cell Disorders;
Gene Mutations;
Dysplasia;
cytopenias;
Malignancies;
Acute Myeloid Leukemia;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Myelodysplastic Syndromes

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

Myelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal. There are limited treatment options for MDS. Researchers want to learn more through this natural history study so they can develop better treatments.

Objective:

To study the natural course of MDS and MDS/myeloproliferative neoplasms (MPN) and collect biological samples that can help researchers understand the disease.

Eligibility:

People with suspected or confirmed MDS or MDS/MPN. Healthy donors are also needed. They can be people who are scheduled to donate bone marrow at NIH for a relative, or they may be providing bone marrow in another study.

Design:

Participants will be screened with a medical history.

Participants will have a physical exam. They will give blood and urine samples. They will discuss their symptoms, medications, and ability to perform their normal activities. They will complete surveys about how they are feeling.

Participants will have a bone marrow biopsy. A needle will be inserted through a small cut. Bone marrow will be removed. A small piece of bone may be removed.

Participants may have an optional skin biopsy.

Participants may give optional saliva and stool samples. They may collect these samples at home and mail them to NIH.

Participants may undergo optional apheresis. One or two needles or intravenous (IV) lines will be placed in their arm, neck, or groin veins. Blood will be removed. A machine will separate out the white cells. The rest of the blood will be returned to the participant.

Participants will be contacted for follow-up once a year for up to 20 years.

Healthy donors will have marrow collected for this study during their scheduled procedure with no follow-up.

--Back to Top--

Eligibility

INCLUSION CRITERIA - MDS Participants

- Any gender, any age.

- Histologically or cytologically suspected or confirmed myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN), MDS/myeloproliferative neoplasm with ringed sideroblasts and thrombocytosis (MDS/MPN-RS-T), myelodysplastic syndromes/myeloproliferative neoplasms unclassified (MDS/MPN-U), chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), secondary acute myeloid leukemia (sAML) with antecedent MDS or MDS/MPN, or participants who have precursor conditions that are associated with a risk of progression to MDS, including but not limited to clonal hematopoiesis of indeterminate potential (CHIP) and clonal cytopenia of unknown significance (CCUS).

- Participants may have had any amount of prior therapy and may be receiving MDS-directed therapy at time of enrollment.

- Participants must have an identified primary oncologist, hematologist or generalist outside of NIH who agrees to manage participant care and any diagnostic findings provided by this study.

INCLUSION CRITERIA - Marrow Control Donor Participants

- Any gender, and must be eligible for marrow donation per NIH Clinical Center requirements.

- No history of hematological malignancies as listed as inclusion in 'Inclusion Criteria - MDS Participants' or current autoimmune disease.

- Must be scheduled for bone marrow harvest for clinical application (e.g., marrow donation); or, if being evaluated for malignancy, have a clinical bone marrow aspirate scheduled (e.g., to rule out bone marrow involvement).

INCLUSION CRITERIA - All Participants

- Stated willingness to comply with all study procedures and availability for the duration of the study.

- Ability of participant or parent/guardian to understand and the willingness to sign a written consent document.

EXCLUSION CRITERIA - All Participants

-Uncontrolled intercurrent illness, psychiatric illness, or other that would limit compliance with study requirements, or at the investigator s discretion.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Kathy McGraw, Ph.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 41
Room B622
41 Center Drive
Bethesda, Maryland 20892
(240) 760-7134
kathy.mcgraw@nih.gov

Rebecca Alexander
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4-3152
10 Center Drive
Bethesda, Maryland 20892
(240) 781-4037
rebecca.alexander@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT05350748

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