Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies

Myelodysplastic Syndromes Clinical Trial

Official title: Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies

Status Recruiting

Clinical Trial Summary

Background:

Myelodysplastic syndromes (MDS) are disorders of blood stem cells that can develop into blood cancers. Treatment options are limited. To find better treatments, researchers need to better understand how MDS develops. To do that, they must be able to compare biospecimens from people with the disease to those of healthy people.

Objective:

This study will create a database of biospecimens collected from healthy volunteers.

Eligibility:

Healthy people aged 18 and older.

Design:

Participants will be screened. They will have a physical exam with blood and urine tests.

Up to 5 types of samples will be collected on 1 or more days within 1 month of screening:

Blood: Blood will be drawn by inserting a needle into a vein.

Saliva: Participants will scrape the insides of their cheeks with a brush.

Stool: Participants will be given a container to collect stool at home. They will use a prepaid envelope to mail in the sample.

Bone marrow: A sample of the soft tissue inside the bones will be drawn out. The area to be biopsied, usually the lower back, will be numbed. A needle will be inserted through a small cut to remove the sample. Participants' pain will be monitored; additional numbing medicine may be used.

Skin: A piece of skin about 1/6 of an inch across will be cut away. Stitches may be used to close the wound. Participants will return to the clinic to have the stitches removed.

Participants do not have to provide all of the samples listed. They will give each sample only once.

Clinical Trial Description

Background:

• Myelodysplastic syndromes (MDS) are heterogeneous stem cell disorders characterized by ineffective hematopoiesis resulting in cellular dysplasia, peripheral cytopenias, and increased risk for transformation to acute myeloid leukemia (AML).

• There are limited treatment options, all of which have unimpressive response rates and limited response durations, with the only potential cure being hematopoietic stem cell transplant (HSCT). Unfortunately, as a disease of the elderly (average age of diagnosis >65 years), most participants are not eligible for HSCT due to advanced age and other comorbidities.

• It is critical we further elucidate the processes that lead to disease manifestation to develop novel therapeutic strategies and alter the natural history of the disease.

• In order to understand the biology of the disease, it is critical to have control biospecimens from healthy individuals to delineate the mechanisms driving disease pathogenesis.

Objective:

-To create a database of analyzed biospecimens collected from healthy volunteers.

Eligibility:

• Age >= 18 years old

• Healthy volunteers as confirmed by clinical evaluation

Design:

• This is a trial to analyze samples from healthy volunteers collected at NIH Clinical Center.

--Participants = will be asked to provide blood, and/or bone marrow, and other samples (skin biopsy samples, saliva, stool samples).

• The total protocol accrual goal is 1,000 participants. Enrollment is expected to take place over approximately 20-50 years. ;

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Neoplasms

• NCT number: NCT05588154
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Rebecca Alexander
• Phone: (240) 781-4037
• Email: rebecca.alexander@nih.gov
• Status: Recruiting
• Start date: January 11, 2023
• Completion date: December 1, 2052