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Trial record 17 of 438 for:    Recruiting, Not yet recruiting, Available Studies | "Tissue Donors"

Long-Term Follow-up of People Undergoing Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT03000244
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

People who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow or an immune system that is damaged. They get stem cells from a donor who is a relative. Researchers want to study stem cell donors and recipients to learn about the long-term effects of HCT. They want to learn how the stem cells change and how to improve their ability to fight cancer.

Objective:

To provide long-term follow-up care for people who underwent or will undergo HCT. To collect data, blood, and tissue samples to learn about late complications after HCT.

Eligibility:

Adults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or more from the date of HCT. The stem cell donors for these recipients are also needed.

Design:

Recipients will have 1 visit each year. They will have a physical exam. They will answer questions about their medical history and health. They will receive screening and surveillance testing. They will complete brief questionnaires.

Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue in their cheek or skin or bone marrow biopsy).

Recipients will give their current address and phone number, and the same data for one or two other people, who can get in contact with them.

After the first visit at the clinic, some recipients may see a doctor close to home to get the necessary information and send it to NIH.

Donors will come to the clinic for 1 visit. They will answer questions about their medical history. Blood samples will be taken.


Condition or disease
Hematopoietic Stem Cell Transplantation Tissue Donors

Detailed Description:

Background:

  • Patients who survive more than 3 years after allogeneic hematopoietic stem cell transplantation (HCT) have a high probability of being cured from their underlying disease; however, mortality rates remain 4 to 9-fold higher than the general population for at least 30 years after HCT.
  • The most common causes of late mortality in HCT survivors include second malignancies, relapsed/recurrent disease, infections, chronic graft-versus-host disease (GVHD), respiratory diseases, and cardiovascular diseases.
  • Guidelines for recommended screening and preventive practices for long-term survivors after HCT have been developed, and can be implemented to detect or prevent late complications after HCT.
  • Understanding the pattern of immune reconstitution and immune dysregulation after HCT may help to elucidate the root mechanisms of late complications.

Objective:

-To collect clinical data on patients and late complications after HCT

Eligibility:

  • Patients who underwent HCT for any indication and are surviving one year or more from the date of HCT OR patients who will be undergoing HCT on an ETIB protocol.
  • Related stem cell donors of patients meeting the above criteria who participated or will be participating as a donor of stem cells or leukocytes.
  • Age greater than or equal to 4 years
  • Any active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.

Design:

  • Prospective, longitudinal study of the natural history of long-term survivors after HCT.
  • Clinical data on post-transplant complications and peripheral blood samples will be collected at yearly evaluations by the Principal Investigator, LAI, AI or representative investigator of the original HCT protocol.
  • If patient develops complications such as new cancers, relapsed disease, new hematologic malignancy or PTLD they can be exempt from required evaluations, and followed for survival and causes of death (management of complications as per primary team).
  • As this is a longitudinal registry study without any planned intervention, there is no formal statistical analysis plan or accrual goal; descriptive data will be reported.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : August 12, 2021
Estimated Study Completion Date : August 12, 2021

Group/Cohort
1/Patients
Patients who underwent hematopoietic stem cell transplant for any indication (malignant ornon-malignant).
2/Donors
Related stem cell donors of those in Patients cohort.
3/Parents of patients
Parents/guardians of minors enrolled in cohort 1



Primary Outcome Measures :
  1. Basic characteristics of the patient population. [ Time Frame: At death. ]
    Survival


Secondary Outcome Measures :
  1. Monitoring of late effects after stem cell transplant for patients of ETIB protocols [ Time Frame: Ongoing throughout study ]
    Survival and observation of long-term outcomes.

  2. Provide a mechanism to ensure implementation of standard of carerecommendations for post-transplant followup [ Time Frame: Ongoing throughout study ]
    Observation of adherence and effects of standard of carerecommendations

  3. Obtain blood and tissue samples to study and document immunologicreconstitution after stem cell transplant [ Time Frame: Ongoing throughout study ]
    Immune monitoring for analysis

  4. Obtain blood samples from stem cell transplant donors to study howbiological factors related to the donor are associated with latecomplications [ Time Frame: Ongoing throughout study ]
    Studying donor samples for potential correlations to transplantrecipient complications.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have received an allogeneic stem cell transplant as well as donors of stem cells who are related to the patients who are study participants. Parents of minor recipients may also be enrolled to complete surveys. Participants can be from any community or co-enrolled on another NIH protocol.
Criteria
  • INCLUSION CRITERIA FOR PATIENT SUBJECTS:
  • Patients who underwent HCT for any indication (malignant or non-malignant) and are surviving one year or more from the date of HCT (patients may be at any time point after HCT as long as it is greater than or equal to 1 year) OR patients who will be undergoing HCT for any indication (malignant or non-malignant) on an ETIB protocol. Patients do not need to have been transplanted under an ETIB protocol.
  • Age greater than or equal to 4 years
  • Ability of patient or patient s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
  • Patients will need to have a primary care physician that will provide continued comprehensive care throughout the patient s participation in the study.

EXCLUSION CRITERIA FOR PATIENT SUBJECTS:

-Patients with active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.

INCLUSION CRITERIA FOR DONOR SUBJECTS:

  • Related stem cell donors of patients meeting the above criteria as a donor of stem cells or leukocytes
  • Age greater than or equal to 4 years
  • Ability of patient or patient s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed

consent document

INCLUSION CRITERIA FOR PARENTS COMPLETING SURVEYS:

  • Parents/guardians of minors enrolled on the study who have undergone HCT
  • Willingness to complete surveys about the minor that underwent HCT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000244


Contacts
Contact: Jennifer L Sadler (240) 760-6172 jennifer.sadler@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Z Pavletic, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03000244     History of Changes
Other Study ID Numbers: 170027
17-C-0027
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 7, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Natural History
HCT