NCT00695123

Screening for Subjects to Participate in Studies of Blood Disorders

Completed Last updated 8 April 2021

What this trial tests

trial in Bone Marrow Transplant in 816 participants. Completed in 2 April 2021.

Timeline

3 July 2008

Primary endpoint
2 April 2021

2 April 2021

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	816
Start date	3 July 2008
Primary completion	2 April 2021
Estimated completion	2 April 2021
Sites	1 location across United States

Conditions studied

• Bone Marrow Transplant — all drugs for Bone Marrow Transplant →
• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• G-CSF — all drugs for G-CSF →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Eligibility, any sex, with Bone Marrow Transplant or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine eligibility for participation in research studies on blood disorders conducted by the National Heart, Lung and Blood Institute and the National Institute of Diabetes, Digestive, and Kidney Diseases.

Healthy volunteers, patients with blood disorders under study by NHLBI and NIDDK and potential stem cell donors for patients with blood disorders who are 8 years of age and older may be eligible for this screening protocol. (Healthy volunteers who qualify for research protocols would serve as control subjects.)

Participants undergo the following tests and procedures:

Healthy Volunteers

* Medical history, physical examination, blood tests and urine sample collection.
* Buccal mucosa sample collection. (Cells are collected from the inside of the cheek by gentle scraping with a bristly brush.)
* Bone marrow aspiration (only for volunteers 18 years of age and older).

Potential Stem Cell Donor

-Same as for healthy volunteers plus evaluations that may include electrocardiogram, echocardiogram, imaging studies (X-rays, CT scans, MRI scans and others), heart evaluation, and lung function tests.

Patient with Blood Disorder

* Same as for stem cell donors plus additional evaluations and treatments that may include radiation oncology evaluation, catheter placement, blood transfusions, kidney and liver biopsies. Short courses of drug treatment for induction of fetal hemoglobin in sickle cell patients, and/or iron chelation in patients receiving chronic red cell transfusions may be included as well.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. SENP1, but not fetal hemoglobin, differentiates Andean highlanders with chronic mountain sickness from healthy individuals among Andean highlanders.
   Hsieh MM, Callacondo D, Rojas-Camayo J, Quesada-Olarte J, et al · · 2016 · cited 20× · PMID 26952840 · DOI 10.1016/j.exphem.2016.02.010