Cervical CancersNCT07594327
Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer
An observational study of Cervical Cancers and Vaginal Cancers, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancers, Vaginal Cancers, Vulvar Cancers
- How many people
- 21 participants
- Where
- 1 siteFinland
- Study dates
- May 2026to Oct 2026
- How long will I take part?
- 3 Months
- 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: Patients who underwent pelvic exenteration for gynecologic cancer at Tampere University Hospital on or after January 1, 2000
Who may be able to join
- patient age over 18 years
- a diagnosis of gynecologic cancer
- having undergone exenteration surgery on or after January 1, 2000 (at least 6 months prior)
- the ability to read and write Finnish
Who cannot join
- cognitive and/or neurological disease that affects physical functioning and may therefore influence sexual functioning or make it difficult to respond to the questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pelvic Exenteration as a Curative Option in Recurrent Gynecological Cancer: Oncological Outcomes and Impact on Quality of Life and Sexuality
Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible.
The aim of this study is to examine the quality of life and sexuality of patients who have undergone pelvic exenteration.
Read more
This observational cross-sectional study utilizes internationally validated questionnaires assessing quality of life and sexual function: EORTC QLQ-C30, EORTC QLQ-CX24, and PISQ-12.
The findings of this study will provide important guidance for the selection and planning of pelvic exenteration. Improved understanding of postoperative quality of life will support patient selection and enable more comprehensive and individualized patient counseling.
Read the detailed description
The investigators will invite living patients who have undergone pelvic exenteration for gynecological cancer at Tampere University Hospital since January 1, 2000, to participate in the study, provided that at least six months have elapsed since the surgery.
The patients are first contacted by telephone to inform them about the study. The investigators will then send an information letter regarding participation, along with questionnaires assessing quality of life and sexuality. There are 21 living patients, most of whom have had cervical cancer. Particular interest will be given to patients who have undergone neovaginal reconstruction, and additional sexuality-related questions have been developed specifically for these patients.
In addition, the medical records of all patients who have undergone pelvic exenteration for gynecological cancer since January 1, 2000, are retrospectively reviewed. Oncological outcomes after pelvic exenteration, factors affecting prognosis, and postoperative complications are assessed.
- Conditions
- Cervical Cancers, Vaginal Cancers, Vulvar Cancers, Endometrial Cancer, Gynecologic Cancers
- Keywords
- Pelvic exenteration, Quality of life, Sexuality
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Endometrial Neoplasms, Sexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire
The EORTC QLQ-C30 is a 30-item questionnaire measuring the quality of life (QoL) of cancer patients, developed by the European Organisation for Research and Treatment of Cancer (EORTC). It assesses physical, psychological, and social functioning.
Measured: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
Self-reporterd quality of life measured by EORTC QLQ-CX24 questionnaire
The EORTC QLQ-CX24 is a 24-item questionnaire, designed to assess disease-specific and treatment-specific aspects of quality of life in patients with cervical cancer. It is developed by the European Organisation for Research and Treatment of Cancer (EORTC).
Measured: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
Self-reported sexuality assessed by the PISQ-12 questionnaire with additional study-specific questions
The PISQ-12 questionnaire is designed for patients with urinary incontinence or pelvic organ prolapse. However, it also includes useful questions for patients undergoing pelvic exenteration. In addition, the investigators have developed and included their own questions specifically tailored for patients with a neovagina.
Measured: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Cross-sectional
- Enrolment
- 21 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594327
- Sponsor's protocol ID
- R25065
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Exenteration as a Curative Option in Recurrent Gynecological Cancer: Oncological Outcomes and Impact on Quality of Life and Sexuality
- ClinicalTrials.gov ID
- NCT07594327
- Acronym / sponsor ID
- R25065
- Conditions
- Cervical Cancers, Vaginal Cancers, Vulvar Cancers, Endometrial Cancer, Gynecologic Cancers
- Keywords
- Pelvic exenteration, Quality of life, Sexuality
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 May 2026 (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.
Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible.
The aim of this study is to examine the quality of life and sexuality of patients who have undergone pelvic exenteration.
This observational cross-sectional study utilizes internationally validated questionnaires assessing quality of life and sexual function: EORTC QLQ-C30, EORTC QLQ-CX24, and PISQ-12.
The findings of this study will provide important guidance for the selection and planning of pelvic exenteration. Improved understanding of postoperative quality of life will support patient selection and enable more comprehensive and individualized patient counseling.
Detailed description
The investigators will invite living patients who have undergone pelvic exenteration for gynecological cancer at Tampere University Hospital since January 1, 2000, to participate in the study, provided that at least six months have elapsed since the surgery.
The patients are first contacted by telephone to inform them about the study. The investigators will then send an information letter regarding participation, along with questionnaires assessing quality of life and sexuality. There are 21 living patients, most of whom have had cervical cancer. Particular interest will be given to patients who have undergone neovaginal reconstruction, and additional sexuality-related questions have been developed specifically for these patients.
In addition, the medical records of all patients who have undergone pelvic exenteration for gynecological cancer since January 1, 2000, are retrospectively reviewed. Oncological outcomes after pelvic exenteration, factors affecting prognosis, and postoperative complications are assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent pelvic exenteration for gynecologic cancer at Tampere University Hospital on or after January 1, 2000
Key inclusion criteria (4 listed)
- patient age over 18 years
- a diagnosis of gynecologic cancer
- having undergone exenteration surgery on or after January 1, 2000 (at least 6 months prior)
- the ability to read and write Finnish
Key exclusion criteria (1 listed)
- cognitive and/or neurological disease that affects physical functioning and may therefore influence sexual functioning or make it difficult to respond to the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire
Time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
The EORTC QLQ-C30 is a 30-item questionnaire measuring the quality of life (QoL) of cancer patients, developed by the European Organisation for Research and Treatment of Cancer (EORTC). It assesses physical, psychological, and social functioning.
Self-reporterd quality of life measured by EORTC QLQ-CX24 questionnaire
Time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
The EORTC QLQ-CX24 is a 24-item questionnaire, designed to assess disease-specific and treatment-specific aspects of quality of life in patients with cervical cancer. It is developed by the European Organisation for Research and Treatment of Cancer (EORTC).
Self-reported sexuality assessed by the PISQ-12 questionnaire with additional study-specific questions
Time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
The PISQ-12 questionnaire is designed for patients with urinary incontinence or pelvic organ prolapse. However, it also includes useful questions for patients undergoing pelvic exenteration. In addition, the investigators have developed and included their own questions specifically tailored for patients with a neovagina.
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 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancers and Vaginal Cancers, run by Tampere University Hospital at 1 site in Finland.
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 4 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: enrolling by invitation, as of the sponsor's last update on 22 May 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 Finland. 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?
Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire (time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration). The study lists 3 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 22 May 2026.