Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05588154
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-10-19
Brief Title:
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
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Blood Bone Marrow Skin Saliva and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 16 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
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 16 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
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 andor bone marrow and other samples skin biopsy samples saliva stool samples
The total protocol accrual goal is 1000 participants Enrollment is expected to take place over approximately 20-50 years
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 andor bone marrow and other samples skin biopsy samples saliva stool samples
The total protocol accrual goal is 1000 participants Enrollment is expected to take place over approximately 20-50 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000975-C | None | None | None |