RECRUITING

SC2i Tissue and Data Repository Protocol

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. The samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additonal protocols to use the samples will be submitted as separate protocols.

Official Title

Surgical Critical Care InitiativeTissue and Data Acquisition Protocol

Quick Facts

Study Start:2014-09-09

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02182180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems) * Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury. * Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.	* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.

Inclusion Criteria

Exclusion Criteria

* Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)
* Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.
* Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.

* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.

Contacts and Locations

Principal Investigator

CAPT Eric Elster, MD, US Navy

STUDY_DIRECTOR

Uniformed Services University of the Health Sciences

Allan M. Kirk, MD, PhD

PRINCIPAL_INVESTIGATOR

Duke University

Timothy G Buchman, Ph.D, MD

PRINCIPAL_INVESTIGATOR

Emory University

Christopher J. Dente, MD

PRINCIPAL_INVESTIGATOR

Grady Hospital

Benjamin K Potter, MD, FACS

PRINCIPAL_INVESTIGATOR

Uniformed Services University - Walter Reed Surgery

Study Locations (Sites)

Grady Health Systems

Atlanta, Georgia, 30303

United States

Emory University

Atlanta, Georgia, 30322

United States

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889

United States

Duke University Health Systems

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

CAPT Eric Elster, MD, US Navy, STUDY_DIRECTOR, Uniformed Services University of the Health Sciences
Allan M. Kirk, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University
Timothy G Buchman, Ph.D, MD, PRINCIPAL_INVESTIGATOR, Emory University
Christopher J. Dente, MD, PRINCIPAL_INVESTIGATOR, Grady Hospital
Benjamin K Potter, MD, FACS, PRINCIPAL_INVESTIGATOR, Uniformed Services University - Walter Reed Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-09-09

Study Completion Date2027-08

Study Record Updates

Study Start Date2014-09-09

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Critical Illness