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RecruitingNCT00700414Updated May 22, 2026

International Pediatric Adrenocortical Tumor Registry

An observational study in Adrenocortical Tumor, sponsored by St. Jude Children's Research Hospital. Recruiting at 5 sites in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by St. Jude Children's Research Hospital · Observational

From the registry’s dates

  • Started Oct 2001; still recruiting 25 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
9,999
Ages
Up to 21 Years
Sex
All
01

Study 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.

Read the detailed description

Adrenocortical tumors (ACT) are rare cancer types that form in the outer layer of the adrenal gland and are very uncommon in children and teenagers. There is variation in pediatric ACT incidence worldwide. In the United States, only about 25 new cases of ACT per million per year, making this a very rare tumor. However, in southern Brazil, the annual incidence of ACT is 15 times that seen in the United States accounting for 3.4-4.2 per million per year.

Molecular studies have revealed that the majority of children with ACT, particularly those younger than 4 years of age, have constitutional TP53 mutations and/or imprinting defects at chromosome 11p as observed in Beckwith Wiedemann syndrome (BWS) patients. Some mutations, as exemplified by the R337H TP53 germline mutation, in which the function of the mutant protein is relatively preserved, the history of cancer in the carriers and their families is relatively unremarkable. In other cases, the TP53 mutated gene encodes a functionally-impaired protein that predicts for a pervasive history of familial cancer (Li-Fraumeni syndrome). Therefore, these observations have implications for genetic counseling of families with childhood ACT and underscore the importance of genotype-phenotype correlations in familial cancer syndromes.

The creation of a rare tumor registry provides a mechanism to collect information that cannot be gathered in a single institution. The analysis of the registry data would permit an overview of the clinical, epidemiological, current treatment standards, and survival data of these patients and thus create opportunities for research. It also may facilitate the development of treatment consensus among investigators who register their patients and help to design future studies. Moreover, the combined Children's Oncology Group (COG) and IPACTR studies are expected to provide meaningful insight into the biology of ACT, including clinical phenotype/genotype relationships, treatment outcome and long-term follow-up data in subjects with this rare tumor. Finally, it would provide data on the long-term consequences of exposure to tumor-secreted androgens (found in more than 80% of the pediatric cases) on children's growth and development.

02

Conditions studied

  • Adrenocortical Tumor
03

In context

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Eligibility criteria

STRATIFICATION ASSIGNMENT:

  • Stratum A: participant suspected or confirmed diagnosis of adrenocortical tumor (ACT)
  • Stratum R: relative of participant with ACT and TP53 mutation who has diagnosis of malignancy
  • Stratum P: biological parent of participant with ACT

Inclusion Criteria - Stratum A (participant with ACT):

  • Age ≤ 21 years old at diagnosis
  • Suspected or confirmed diagnosis of adrenocortical tumor (adenoma, carcinoma or undefined histology).
  • Signed informed consent

Inclusion Criteria - Stratum R (relative):

  • Any age
  • Diagnosis of malignant tumor
  • Signed informed consent

Inclusion Criteria - Stratum P (parent):

  • Biological parent of Stratum A participant
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
9,999 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Participants

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

06

What researchers measure

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

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

07

Study locations

2 of 5 sites recruiting
  • 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
    • Mukund Dole, MD · Contact
    • Jenny Dillon, RN, CCRP · Contact
    • Mukund Dole, MD · Principal investigator
    Recruiting
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    • Raul C Ribeiro, MD · Contact · referralinfo@stjude.org · 866-278-5833
    • Raul C Ribeiro, MD · Principal investigator
    Recruiting
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
    Completed
08

References and documents

Publications

  • 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. PubMed 34675114 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00700414
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Jun 18, 2008
Start date
Oct 1, 2001
Primary completion
Dec 2040 (estimated)
Completion
Dec 2040 (estimated)
Last update
May 22, 2026

Study contacts

Raul C Ribeiro, MD
Contact
referralinfo@stjude.org
866-278-5833
Raul C Ribeiro, MD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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