NCT00700414

Brief Summary

This study aims to collect demographic and medical information including detailed family history of cancer of children and adolescents with adrenocortical tumors in order to learn more about the clinical and epidemiological aspects, treatment modalities, and outcome of patients with this rare disease, worldwide. In addition, investigators at St. Jude Children's Research Hospital (SJCRH) plan to perform molecular studies of tumor cells aimed to clarify the role of the TP53 gene and other genetic pathways in these tumors. They aim to obtain relevant biological material from participants with adrenocortical tumor (ACT), their biological parents, and relatives for determination of the TP53 germline status, molecular studies of the TP53 gene, and other molecular pathways.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
9,999

participants targeted

Target at P75+ for all trials

Timeline
177mo left

Started Oct 2001

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

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 Progress63%
Oct 2001Dec 2040

Study Start

First participant enrolled

October 1, 2001

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
32.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

39.2 years

First QC Date

June 13, 2008

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Collect demographic/medical information, detailed family history of cancer of children/adolescents with adrenocortical tumors, learn more about the clinical and epidemiological aspects, treatment modalities, and outcome of patients

    Annually from diagnosis until no longer being followed, defined as up to 5 years from the date of last follow-up

Study Arms (1)

Participants

Any participant who meets eligibility criteria and consents to participate in the trial.

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Age ≤ 21 years old at diagnosis of adrenocortical tumor. Relatives of the ACT patients of any age with a diagnosis of malignant tumor.

You may qualify if:

  • Age ≤ 21 years old at diagnosis
  • Suspected or confirmed diagnosis of adrenocortical tumor (adenoma, carcinoma or undefined histology).
  • Signed informed consent
  • Any age
  • Diagnosis of malignant tumor
  • Signed informed consent
  • Biological parent of Stratum A participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University

Stanford, California, 94305, United States

COMPLETED

All Children's Hospital/St. Petersburg Hospital

St. Petersburg, Florida, 33701, United States

COMPLETED

The Children's Medical Center

Dayton, Ohio, 45404, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

COMPLETED

Related Publications (1)

  • Pinto EM, Maxwell KN, Halalsheh H, Phillips A, Powers J, MacFarland S, Walsh MF, Breen K, Formiga MN, Kriwacki R, Nichols KE, Mostafavi R, Wang J, Clay MR, Rodriguez-Galindo C, Ribeiro RC, Zambetti GP. Clinical and Functional Significance of TP53 Exon 4-Intron 4 Splice Junction Variants. Mol Cancer Res. 2022 Feb;20(2):207-216. doi: 10.1158/1541-7786.MCR-21-0583. Epub 2021 Oct 21.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample with DNA and RNA; Tumor Tissue (of any histology); Adrenocortical tumors;

MeSH Terms

Conditions

Adrenal Cortex Neoplasms

Condition Hierarchy (Ancestors)

Adrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Raul C Ribeiro, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raul C Ribeiro, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

October 1, 2001

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations