NCT05407480

Brief Summary

The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data. Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress43%
Nov 2022Dec 2030

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

6.1 years

First QC Date

June 2, 2022

Last Update Submit

February 27, 2026

Conditions

StagingTherapeutic Recommendations

Outcome Measures

Primary Outcomes (2)

  • Patient status

    Dead or Alive

    24 months

  • Drugs

    The evaluation of the number of children who remain untreated because of lack of acess to chemotherapy

    24 months

Interventions

ObservationalOTHER

Descriptive data will be collected to evaluation compliance with the protocol and to evaluate outcome

Eligibility Criteria

Age0 Months - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children arriving in one of the participating units : under 18 years of age at diagnosis and suffering from "classical" Hodgkin's disease according to the WHO classification.

You may qualify if:

  • under 18 years of age at diagnosis
  • suffering from "classical" Hodgkin's disease according to the WHO classification.
  • with no history of hematological malignancies or constitutional or acquired immune deficiencies

You may not qualify if:

  • Over 18 years of age at diagnosis
  • A history of hematological malignancies or a history of constitutional or a history of acquired immune deficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brenda Mallon

Paris, France, 94805, France

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • FATEN Ben Ayed, Professeur

    French Africa Pediatric Oncology Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda MS MALLON

CONTACT

0033 142115411brenda.mallon@gustaveroussy.fr

FATEN Ben Ayed, Professeur

CONTACT

faten.fedhila@yahoo.fr

Study Design

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

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

November 15, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

FR(1)