Cervical CarcinomaNCT00791635
Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer
An observational study of Cervical Carcinoma and Endometrial Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Endometrial Carcinoma, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2008to 30 Sep 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a history of gynecologic malignancy who have undergone or are being offered a pelvic exenteration
Who may be able to join
- Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology
- Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy
- Patients must be suitable candidates for surgery (in case of prospective collection)
- Patients who have signed an approved informed consent
- Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease
- Women must be able to read and write in either Spanish or English
Who cannot join
- Patients with contraindications to surgery
- Patients unwilling or unable to complete self-administered questionnaires
- Patients who do not read or speak English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the types of complications experienced by women who undergo pelvic exenteration at University of Texas (UT) MD Anderson Cancer Center.
II. To determine whether the number of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center differ by vaginal and bladder reconstruction types.
SECONDARY OBJECTIVES:
- To evaluate pathologic predictors of recurrence including histology, size of tumor, and distance of closest margin.
II. To longitudinally assess quality of life, sexual functioning, and symptoms in women who have undergone pelvic exenteration for gynecologic malignancies.
III. To assess the impact of certain preoperative factors (albumin, electrolyte levels, body mass index) on the occurrence of post-operative complications.
IV. To determine if preoperative positron emission tomography (PET)/computed tomography (CT) correlates with pathologic findings at the time of surgery.
- To calculate time to recurrence, overall survival, and disease-free survival of patients who undergo pelvic exenteration and correlate to key demographic, clinical, and pathologic factors.
OUTLINE:
RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of quality of life (QOL) questionnaires.
PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.
Patients who undergo surgery are followed up every 3 months for the first 2 years, and then every 6 months for 3 years.
- Conditions
- Cervical Carcinoma, Endometrial Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaires) | RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires.
PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits. Receives: 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.
Number of surgical complications
Will determine whether the number of surgical complications varies by vaginal and bladder reconstruction type.
Measured: 4 years
Short-term and long-term complications
Will calculate incidence with exact 95% confidence intervals, and will calculate summary statistics. Will create the statistics using both cohorts of patients together. Will also do this separately by cohort and by vaginal reconstruction type as well as by bladder reconstruction type. A Wilcoxon rank-sum test will be used to determine whether there is a difference in number of complications by vaginal reconstruction type and by bladder reconstruction type. This will be conducted separately for each cohort. Finally, will create a Poisson regression model using both cohorts of patients with terms for cohort, vaginal reconstruction type and bladder reconstruction type as well as certain preoperative factors (albumin, electrolyte levels, body mass index) that might be predictive of number of complications.
Measured: 4 years
Quality of life
Will summarize composite scores of the quality of life surveys by time from exenteration. This will be done separately for the retrospectively recruited patients and the prospectively recruited patients. Will also summarize information by year of surgery. To determine how quality of life changes over time, will create longitudinal models for each survey instrument given to the women. The two cohorts of women will initially be analyzed separately. A second model will be created using all patients that has terms for cohort, vaginal reconstruction type and bladder reconstruction type to determine whether these terms have an effect upon quality of life.
Measured: Up to 5 years
Recurrence
Will calculate median time to recurrence in patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of recurrence such as histology, size of tumor, and distance of closest margin.
Measured: Up to 5 years
Overall survival
Will calculate overall survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.
Measured: Up to 5 years
Disease-free survival
Will calculate disease-free survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study start11 Jul 2008
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela T Soliman, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791635
- Sponsor's protocol ID
- 2008-0095
- Other IDs
- NCI-2020-07746, 2008-0095
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2008
- Last updated
- 14 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
- ClinicalTrials.gov ID
- NCT00791635
- Acronym / sponsor ID
- 2008-0095
- Conditions
- Cervical Carcinoma, Endometrial Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Jul 2008 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Nov 2008 (estimated)
- 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.
The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the types of complications experienced by women who undergo pelvic exenteration at University of Texas (UT) MD Anderson Cancer Center.
II. To determine whether the number of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center differ by vaginal and bladder reconstruction types.
SECONDARY OBJECTIVES:
- To evaluate pathologic predictors of recurrence including histology, size of tumor, and distance of closest margin.
II. To longitudinally assess quality of life, sexual functioning, and symptoms in women who have undergone pelvic exenteration for gynecologic malignancies.
III. To assess the impact of certain preoperative factors (albumin, electrolyte levels, body mass index) on the occurrence of post-operative complications.
IV. To determine if preoperative positron emission tomography (PET)/computed tomography (CT) correlates with pathologic findings at the time of surgery.
- To calculate time to recurrence, overall survival, and disease-free survival of patients who undergo pelvic exenteration and correlate to key demographic, clinical, and pathologic factors.
OUTLINE:
RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of quality of life (QOL) questionnaires.
PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.
Patients who undergo surgery are followed up every 3 months for the first 2 years, and then every 6 months for 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaires) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationRETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires. PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a history of gynecologic malignancy who have undergone or are being offered a pelvic exenteration
Key inclusion criteria (6 listed)
- Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology
- Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy
- Patients must be suitable candidates for surgery (in case of prospective collection)
- Patients who have signed an approved informed consent
- Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease
Key exclusion criteria (3 listed)
- Patients with contraindications to surgery
- Patients unwilling or unable to complete self-administered questionnaires
- Patients who do not read or speak English or Spanish
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaires) |
Primary outcome
Number of surgical complications
Time frame: 4 years
Will determine whether the number of surgical complications varies by vaginal and bladder reconstruction type.
Short-term and long-term complications
Time frame: 4 years
Will calculate incidence with exact 95% confidence intervals, and will calculate summary statistics. Will create the statistics using both cohorts of patients together. Will also do this separately by cohort and by vaginal reconstruction type as well as by bladder reconstruction type. A Wilcoxon rank-sum test will be used to determine whether there is a difference in number of complications by vaginal reconstruction type and by bladder reconstruction type. This will be conducted separately for each cohort. Finally, will create a Poisson regression model using both cohorts of patients with terms for cohort, vaginal reconstruction type and bladder reconstruction type as well as certain preoperative factors (albumin, electrolyte levels, body mass index) that might be predictive of number of complications.
Quality of life
Time frame: Up to 5 years
Will summarize composite scores of the quality of life surveys by time from exenteration. This will be done separately for the retrospectively recruited patients and the prospectively recruited patients. Will also summarize information by year of surgery. To determine how quality of life changes over time, will create longitudinal models for each survey instrument given to the women. The two cohorts of women will initially be analyzed separately. A second model will be created using all patients that has terms for cohort, vaginal reconstruction type and bladder reconstruction type to determine whether these terms have an effect upon quality of life.
Recurrence
Time frame: Up to 5 years
Will calculate median time to recurrence in patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of recurrence such as histology, size of tumor, and distance of closest margin.
Overall survival
Time frame: Up to 5 years
Will calculate overall survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.
Disease-free survival
Time frame: Up to 5 years
Will calculate disease-free survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.
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 14 Sep 2026.
- MD Anderson Cancer CenterLink 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. This study is not recruiting at the moment.
Pamela T Soliman 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 Cervical Carcinoma and Endometrial Carcinoma, 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of surgical complications (time frame: 4 years). The study lists 6 primary outcomes in all. 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 14 Sep 2026.