Cervical CancerNCT02026648
Outcome of Women With Cervical Cancer
An observational study of Cervical Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix over the same period. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to May 2016
- 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 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: the cases with cervical cancer
Who may be able to join
- Time interval: from 1991 to date.
- Comprehensive surgical staging, debulking procedure, radiotherapy or chemotherapy.
- All female patients with cervical cancer who underwent treatment for cervical cancer at Far Eastern Memorial Hospital.
- All the patients diagnosed as cervical cancer, especially for women with adeno- and adenosquamous carcinoma.
- To review:
- Clinical data: including age at diagnosis, presenting symptoms, gravidity, parity, menstrual history, body mass index, history of diabetes, hypertension, personal history of cancer and staging.
Show all 9Show fewer
- Pathologic information: deep stromal invasion, lymph-vascular space invasion, lymph node involvement, parametrium invasion, vaginal cut end and tumor size.
- Survival data: disease-free and overall survival.
- Radiation report, Chemotherapy treatment, operation, discharge and admission note.
Who cannot join
- Not comprehensive staging/debulking procedure.
- Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
- Female minors or disabled persons.
Trial locations and contacts
1 site in 1 country.
About this study
Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix over the same period.
Our understanding of the natural history and optimal management of AC is limited. It appears that AC and SCC of the cervix behave differently. They are different in epidemiology, prognostic factors, and patterns of failure after similar treatments. Available data suggest that they may also differ in their response to treatment. We postulate that new treatment strategies specifically tailored to AC should be explored.
However, there is few data about outcome of cervical cancer in Taiwan. So we propose this proposal for retrospective analysis of clinicopathological parameters and outcomes in patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous carcinoma.
- Conditions
- Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases with cervical cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of women with cervical cancer
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 81 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
- NCT02026648
- Sponsor's protocol ID
- 102159-E
- Status last verified
- Feb 2016
- First submitted
- 1 Jan 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Women With Cervical Cancer
- ClinicalTrials.gov ID
- NCT02026648
- Acronym / sponsor ID
- 102159-E
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Jan 2014 (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.
Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix over the same period.
Our understanding of the natural history and optimal management of AC is limited. It appears that AC and SCC of the cervix behave differently. They are different in epidemiology, prognostic factors, and patterns of failure after similar treatments. Available data suggest that they may also differ in their response to treatment. We postulate that new treatment strategies specifically tailored to AC should be explored.
However, there is few data about outcome of cervical cancer in Taiwan. So we propose this proposal for retrospective analysis of clinicopathological parameters and outcomes in patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous carcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases with cervical cancer | – | – |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the cases with cervical cancer
Key inclusion criteria (9 listed)
- Time interval: from 1991 to date.
- Comprehensive surgical staging, debulking procedure, radiotherapy or chemotherapy.
- All female patients with cervical cancer who underwent treatment for cervical cancer at Far Eastern Memorial Hospital.
- All the patients diagnosed as cervical cancer, especially for women with adeno- and adenosquamous carcinoma.
- To review:
Key exclusion criteria (3 listed)
- Not comprehensive staging/debulking procedure.
- Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
- Female minors or disabled persons.
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
Outcome of women with cervical cancer
Time frame: 20 years
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 7 Sep 2016.
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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 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 9 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: finished, as of the sponsor's last update on 7 Sep 2016. 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?
Outcome of women with cervical cancer (time frame: 20 years). 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 7 Sep 2016.