NCT07575815

Brief Summary

This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
29mo left

Started Oct 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year.

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

UT MD Anderson patients

You may qualify if:

  • To be eligible to participate in this study, an individual must meet all of the following criteria:
  • Provision of signed and dated informed consent from a parent or legal guardian.
  • For children age 7 and older, provision of informed assent in addition to parental consent, consistent with institutional guidelines.
  • Stated willingness of parent/guardian and child (as appropriate) to comply with study procedures (i.e., observation during scheduled radiation therapy appointments).
  • Male or female, ages 2-12 years.
  • Scheduled to undergo radiation therapy at MD Anderson Cancer Center.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Has already completed the simulation session for radiation therapy prior to enrollment.
  • Declines parental consent or, when applicable, child assent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Susan L McGovern, MD, PHD

    UT MD Anderson

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan L McGovern, MD, PHD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations