NCT00904579

Brief Summary

Background:

  • Solid organ transplantation provides life-saving treatment for end-stage organ disease but is associated with an increased cancer risk because of the need for long-term immunosuppression
  • End-stage renal disease (ESRD), the most common type of end-stage organ disease leading to transplant, is itself linked to increased risk for some cancers
  • The role of immunosuppression and other factors causing cancer in this setting are not fully understood. Objectives:
  • To characterize cancer risk in transplant recipients and identify risk factors.
  • To characterize risk for transmission of cancer from organ donors to recipients.
  • To describe cancer risk in ESRD. Eligibility: Patients are not required for this study. Data are gathered from existing databases of ESRD patients, organ transplant patients and cancer registries. Design:
  • Databases of 1) U.S. transplant recipients, donors and wait list candidates and 2) U.S. ESRD patients will be linked to multiple U.S. cancer registries to identify cancers in transplant recipients and ESRD patients.
  • The spectrum of cancer risk in transplant recipients and ESRD patients will be evaluated in detail.
  • The cancer risk in transplant recipients will be examined in relation to whether the donors had cancer.
  • The proposed cancer risk factors (e.g., underlying medical condition, infection with cancer-causing viruses, immunosuppressive medications) documented in transplant and ESRD files will be studied for association with increased risk of particular types of cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,929,901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

13.8 years

First QC Date

May 16, 2009

Last Update Submit

April 24, 2020

Conditions

Immunocompromised HostOrgan TransplantationCancer

Keywords

Organ TransplantsImmunosuppressionCancerEnd Stage Renal DiseaseESRDCancer Risk

Outcome Measures

Primary Outcomes (1)

  • Cancer

    Cancer patients who have had organ transplants identified through the transplant and cancer registries.

    End of study

Study Arms (1)

1

Cancer patients who have had organ transplants identified through the transplant and cancer registries.

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients who have had organ transplants identified through the transplant and cancer registries.@@@

* This study will include as subjects all individuals included in the transplant data set. All U.S. solid organ transplant recipients, candidates for transplant, and living related donors. In addition, the study will include all individuals in the U.S. ESRD data set.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

California Cancer Registry

Sacramento, California, 95811, United States

Location

Colorado Cancer Registry

Denver, Colorado, 12206, United States

Location

Connecticut Cancer Registry

Hartford, Connecticut, 06134, United States

Location

Georgia Cancer Registry

Atlanta, Georgia, 30303, United States

Location

Iowa Cancer Registry

Iowa City, Iowa, 52242, United States

Location

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

New Jersey Cancer Registry

New Brunswick, New Jersey, 08901, United States

Location

New York Cancer Registry

Albany, New York, 12206, United States

Location

Seattle Cancer Registry

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

NeoplasmsKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric A Engels, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2009

First Posted

May 19, 2009

Study Start

July 1, 2006

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

US(9)