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Trial record 10 of 14 for:    mark stegall transplant

The TOGETHER Project - Kidney RNA-seq Validation (TOGETHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874299
Recruitment Status : Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

Brief Summary:
The researchers are trying to develop a way to measure the risk of rejection through the validation of a blood test.

Condition or disease
Kidney Transplant Rejection

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients—RNA-seq Signature Validation
Actual Study Start Date : November 17, 2016
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Kidney Transplant Receipients



Primary Outcome Measures :
  1. To validate the use of a RNA-seq based peripheral blood assay in renal transplant recipients. [ Time Frame: 3 years ]
    The study will validate the ability of a peripheral blood assay to assess the risk of biopsy proven rejection.


Biospecimen Retention:   Samples With DNA
Blood draws collected at 1 month, 4 month, 6 month, 9 months, 12 months and for cause.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Renal transplant recipients.
Criteria

Inclusion Criteria:

  • Adult (>/=18 years) renal transplant recipient.
  • Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.

Exclusion Criteria:

-Adult (<18 years) renal transplant recipient.


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): NCT03874299


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

Additional Information:
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Responsible Party: Mark Stegall, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03874299     History of Changes
Other Study ID Numbers: 16-004433
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No