RECRUITING

Childhood Cancer Predisposition Study (CCPS)

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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 Childhood Cancer Predisposition Study (CCPS) is a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a cancer predisposition syndromes (CPS) and their relatives. The central hypothesis is that studying individuals at high risk for childhood cancer creates a unique opportunity for improving the understanding of carcinogenesis, tumor surveillance, early detection, and cancer prevention, which will collectively contribute to improving care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS).

Official Title

Childhood Cancer Predisposition Study (CCPS)

Quick Facts

Study Start:2021-04-22

Study Completion:2030-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04511806

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:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be less than 21 years of age at the time of enrollment 2. Have a diagnosis of a specific CPS, whether they have had cancer or not * Based on clinical laboratory testing demonstrating a Pathogenic or Likely Pathogenic germline variant and/or * Based on well-established clinical diagnostic criteria and/or * Based on high clinical suspicion of a specific CPS with clinical laboratory testing demonstrating a variant of uncertain significance (VUS) 1. Be the biologic parent of a Primary Subject and 2. Carry a diagnosis (or obligate diagnosis) of the familial CPS 1. Be the biologic sibling of a Primary Subject and 2. Carry a diagnosis (or obligate diagnosis) of the familial CPS 1. Be the biologic parent or sibling of a Primary Subject and 2. Not carry a diagnosis (or obligate diagnosis) of the familial CPS 1. Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required.	* Individuals with a strong personal or family history of cancer without a genetic or clinical diagnosis of a specific CPS are not eligible for enrollment.

Inclusion Criteria

Exclusion Criteria

1. Be less than 21 years of age at the time of enrollment
2. Have a diagnosis of a specific CPS, whether they have had cancer or not
* Based on clinical laboratory testing demonstrating a Pathogenic or Likely Pathogenic germline variant and/or
* Based on well-established clinical diagnostic criteria and/or
* Based on high clinical suspicion of a specific CPS with clinical laboratory testing demonstrating a variant of uncertain significance (VUS)
1. Be the biologic parent of a Primary Subject and
2. Carry a diagnosis (or obligate diagnosis) of the familial CPS
1. Be the biologic sibling of a Primary Subject and
2. Carry a diagnosis (or obligate diagnosis) of the familial CPS
1. Be the biologic parent or sibling of a Primary Subject and
2. Not carry a diagnosis (or obligate diagnosis) of the familial CPS
1. Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required.

* Individuals with a strong personal or family history of cancer without a genetic or clinical diagnosis of a specific CPS are not eligible for enrollment.

Contacts and Locations

Study Contact

Christopher Porter, MD

CONTACT

4047274881

chris.porter@emory.edu

Principal Investigator

Christopher Porter, MD

PRINCIPAL_INVESTIGATOR

Emory University

Anita Villani, MD

PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Study Locations (Sites)

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Primary Children's Hospital

Salt Lake City, Utah, 84113

United States

Collaborators and Investigators

Sponsor: Emory University

Christopher Porter, MD, PRINCIPAL_INVESTIGATOR, Emory University
Anita Villani, MD, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children

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 Date2021-04-22

Study Completion Date2030-10

Study Record Updates

Study Start Date2021-04-22

Study Completion Date2030-10

Terms related to this study

Keywords Provided by Researchers

Cancer predisposition

Additional Relevant MeSH Terms

Pediatric Cancer