RANDOMIZED STUDY TO PROTECT FROM RADIATION IATROGENIC HYPOTHYROIDISM PATIENTS WITH MEDULLOBLASTOMA (ANY AGE, STAGE AND ANY BIOLOGICAL RISK) AND PEDIATRIC PATIENTS WITH HODGKIN LYMPHOMA AND NON-HODGKIN LYMPHOMA NEEDING RADIATION THERAPY ON THYROID SITE

Phase 1

• Conditions: medulloblastoma, Hodgkin and non-Hodgkin lymphomas; MedDRA version: 20.0Level: PTClassification code 10027107Term: MedulloblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001385-38-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1.Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma BEFORE RADIOTHERAPY (RT) PLANNING INCLUDING THYROID PARENCHYMA without previous primary or secondary hypothyroidism;
2.Written informed consent prior to any study-specific analysis and/or data collection.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;
2.Not signed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified