Locally Advanced Cervical CancerNCT05059119
Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
An observational study of Locally Advanced Cervical Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To investigate the associated risk factors of rectovaginal fistula Read more about this study
- Who is it for?
- Ages 54 to 74 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 54 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: To present cases who developed rectovaginal fistulas after radiotherapy
Who may be able to join
- Rectovaginal fistula Cervical cancer
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
To investigate the associated risk factors of rectovaginal fistula
Read the detailed description
To investigate the associated risk factors of rectovaginal fistula in cervical caner patients after radiotherapy
- Conditions
- Locally Advanced Cervical Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of associated comorbidity or intervention
Rate of associated comorbidity or intervention in patients with rectovaginalfistula
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Sep 2020
- Primary completion25 May 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059119
- Sponsor's protocol ID
- 109104-C
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2021
- Last updated
- 15 Sep 2023
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT05059119
- Acronym / sponsor ID
- 109104-C
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 28 Sep 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.
To investigate the associated risk factors of rectovaginal fistula
Detailed description
To investigate the associated risk factors of rectovaginal fistula in cervical caner patients after radiotherapy
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 54 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To present cases who developed rectovaginal fistulas after radiotherapy
Key inclusion criteria (1 listed)
- Rectovaginal fistula Cervical cancer
Key exclusion criteria (1 listed)
- Nil
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
Rate of associated comorbidity or intervention
Time frame: 12 months
Rate of associated comorbidity or intervention in patients with rectovaginalfistula
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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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.
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 Locally Advanced Cervical Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 15 Sep 2023. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of associated comorbidity or intervention (time frame: 12 months). 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 2023.