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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT05588154

Collaborator

(none)

1,000

Enrollment

Location

358.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Dec 1, 2052

Anticipated Study Completion Date :

Dec 1, 2052

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Healthy volunteers who will donate blood, and/or bone marrow and may donate other samples
Cohort 2 Healthy volunteers who will donate stool samples only

Outcome Measures

Primary Outcome Measures

create a database of analyzed biospecimens [ongoing]
Collection of biospecimens from healthy volunteers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:
Age >= 18 years old
Healthy volunteers
as confirmed by the Principal Investigator or designee based on recent (within 3 months before study intervention(s)) medical history, physical exam, and complete blood count (CBC) analysis in the normal range
The ability of the participant to understand and the willingness to sign a written consent document.

EXCLUSION CRITERIA:

Active illnesses, immunodeficiency, history of opportunistic infection, autoimmune disease, history of or active malignancy, prior organ, bone marrow, or peripheral blood stem cell transplant or antibiotic treatment within 3 months before study intervention(s).

Note: participants with non-melanoma skin cancer or carcinoma in situ of the cervix or breast are eligible.

Current immunosuppressive medication.
Any one of the following symptoms as declared by the participant at least one day per week within 3 months before study intervention(s) (Rome IV criteria)
Diarrhea characterized as frequent (>2) loose stools
Constipation defined as < 3 spontaneous bowel movements per week
Bloating and/or distention
Abdominal pain.
Participants with a history of the human immunodeficiency virus (HIV), hepatitis C (HCV), or hepatitis B (HBV) as confirmed by a seropositive blood test.
Pregnancy confirmed with beta-Human Chorionic Gonadotropin (Beta-HCG) serum or urine pregnancy test performed in women of childbearing potential at screening.
Breastfeeding participants.