NCT05134142

Brief Summary

This study aims to determine the functional outcomes of patients who underwent internal hemipelvectomy with or without reconstruction or external hemipelvectomy for pelvic tumors. Learning about the outcomes of these patients may help researchers determine the long-term effects of different types of hemipelvectomy procedures and may help improve quality of life.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Mar 2013

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

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Study Timeline

Key milestones and dates

Study Progress95%
Mar 2013Apr 2027

Study Start

First participant enrolled

March 27, 2013

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

14.1 years

First QC Date

November 11, 2021

Last Update Submit

May 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy

    All continuous variables including the scoring systems will be described as mean with standard deviation or median with range. Frequencies and percentages will be obtained for all categorical variables. Pediatric participants' data measures will be collected and analyzed separately from the adult populations.

    Through study completion, average of 1 year

Study Arms (1)

Observational (Physical tests, questionnaires, record review)

Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.

Other: Electronic Health Record ReviewOther: Physical Performance TestingOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Undergo medical record review

Observational (Physical tests, questionnaires, record review)

Undergo physical performance testing

Also known as: Physical Fitness Testing, Physical Function Testing
Observational (Physical tests, questionnaires, record review)

Complete assessments

Also known as: Quality of Life Assessment
Observational (Physical tests, questionnaires, record review)

Complete questionnaire

Observational (Physical tests, questionnaires, record review)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients within the institution who have undergone or will undergo a hemipelvectomy.

You may qualify if:

  • Patients within the institution who have undergone or will undergo a hemipelvectomy

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Valerae O Lewis

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 24, 2021

Study Start

March 27, 2013

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations