NCT06340243

Brief Summary

determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet 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

First Submitted

Initial submission to the registry

March 22, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 22, 2024

Last Update Submit

March 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy

    determine if radiotherapy could be safely omitted for early responder patients without compromising outcome, it can be assessed by decrease in lymph node volume ,Volumes are approximated as ellipsoids. If a, b, c denote the principal axes of the ellipsoid the volume is calculated as V= (a x b x c)/2

    2 years

Interventions

radiotherapyRADIATION

radiotherapy

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infants and children around age of (1month to 18 years old) admitted with hodgkin lymphoma in a period of 2 years

You may qualify if:

  • Previously untreated patients younger than 18 years old with classical Hodgkin lymphoma

You may not qualify if:

  • Patients aged more than 18 years old.
  • Patients who died early at presentation before starting chemotherapy
  • diagnosis of nodular lymphocytic predominant Hodgkin lymphoma
  • previous chemotherapy or radiotherapy other (simultaneous) malignancies
  • severe concomitant diseases (eg, immune deficiency syndrome); or known HIV positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 1, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 1, 2024

Record last verified: 2024-03