Malignant Primary Pelvic NeoplasmNCT05134142
Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy
An observational study of Malignant Primary Pelvic Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Primary Pelvic Neoplasm
- What is being tested?
- Electronic Health Record Review, Physical Performance Testing and Quality-of-Life Assessment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2013to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients within the institution who have undergone or will undergo a hemipelvectomy.
Who may be able to join
- Patients within the institution who have undergone or will undergo a hemipelvectomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Valerae O. Lewis, 713-792-5073
Valerae O. Lewis
About this study
Official title: Quality of Life and Function of Patients After Hemipelvectomy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.
SECONDARY OBJECTIVES:
- To determine factors that influence the functional outcomes of these patients following surgery.
II. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.
III. Determine whether type of surgery influences long-term sexual and urinary function.
OUTLINE:
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.
- Conditions
- Malignant Primary Pelvic Neoplasm
- Being tested
- Electronic Health Record Review, Physical Performance Testing, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Undergo medical record review
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Undergo physical performance testing
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete assessments
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Health Record Review; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start27 Mar 2013
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Primary Pelvic NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Valerae O Lewis, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134142
- Sponsor's protocol ID
- PA12-1046
- Other IDs
- NCI-2021-11297, PA12-1046
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Function of Patients After Hemipelvectomy
- ClinicalTrials.gov ID
- NCT05134142
- Acronym / sponsor ID
- PA12-1046
- Conditions
- Malignant Primary Pelvic Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Mar 2013 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.
SECONDARY OBJECTIVES:
- To determine factors that influence the functional outcomes of these patients following surgery.
II. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.
III. Determine whether type of surgery influences long-term sexual and urinary function.
OUTLINE:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (Physical tests, questionnaires, record review) | – | Other: Electronic Health Record Review, Other: Physical Performance Testing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients within the institution who have undergone or will undergo a hemipelvectomy.
Key inclusion criteria (1 listed)
- Patients within the institution who have undergone or will undergo a hemipelvectomy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewUndergo medical record review | Other | Observational (Physical tests, questionnaires, record review) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingUndergo physical performance testing | Other | Observational (Physical tests, questionnaires, record review) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete assessments | Other | Observational (Physical tests, questionnaires, record review) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (Physical tests, questionnaires, record review) |
Primary outcome
Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy
Time frame: Through study completion, average of 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valerae O Lewis principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Primary Pelvic Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerae O Lewis (713-792-5073, volewis@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy (time frame: Through study completion, average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.