Locally Advanced Cervical CancerNCT05779111
A Retrospective Analysis: Whether Five Factors Affect PFS in Patients With Locally Advanced Cervical Cancer
An observational study of Locally Advanced Cervical Cancer and Radiotherapy, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.A retrospective study was conducted to explore the influence of 5 factors on PFS in patients with locally advanced cervical cancer… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer, Radiotherapy
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 10 Dec 2022
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: From May 2016 to July 2021, 183 patients with locally advanced cervical cancer received radiotherapy in our hospital ,with or without chemotherapy.Patients were scored according to 5 factors. PFS were compared between patients with scores greater than or equal to 3 points and those with scores less than 3 points. PFS is defined as the time from the end of treatment to disease progression or the time of the last follow-up 2022-10-01.
Locally advanced cervical cancer patients receiving radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.A retrospective study was conducted to explore the influence of 5 factors on PFS in patients with locally advanced cervical cancer receiving radiotherapy and chemotherapy.
Read the detailed description
In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.5 factors included positive iliac lymph nodes, histological type, tumor size, positive pelvic lymph nodes on both sides, and maximum lymph node diameter greater than 1cm. Different factors give different scores.If the score is higher than 3, the probability of retroperitoneal lymph node metastasis in patients with locally advanced cervical cancer is significantly increased, and the prognosis of patients is affected. Patients with locally advanced cervix receiving radical radiotherapy were scored based on 5 factors.Patients with scores greater than or equal to 3 points were compared with patients with scores less than 3 points.
- Conditions
- Locally Advanced Cervical Cancer, Radiotherapy
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 |
|---|---|---|
| Scores greater than or equal to 3 in patients with locally advanced cervical cancer | Scores greater than or equal to 3 in patients with locally advanced cervical cancer | |
| Patients with locally advanced cervical cancer scored less than 3 points | Patients receiving radiotherapy for locally advanced cervical cancer were scored according to five factors, with a score of less than 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival（PFS）
Whether there are differences in PFS between the two groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start10 Feb 2022
- Primary completion1 Nov 2022
- Study completion10 Dec 2022
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zou Dongling, M.D., Study director, Chongqing University Cancer Hospital Chongqing, Chongqing, China,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779111
- Sponsor's protocol ID
- CQGOG0111
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis: Whether Five Factors Affect PFS in Patients With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05779111
- Acronym / sponsor ID
- CQGOG0111
- Conditions
- Locally Advanced Cervical Cancer, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 22 Mar 2023 (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.
In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.A retrospective study was conducted to explore the influence of 5 factors on PFS in patients with locally advanced cervical cancer receiving radiotherapy and chemotherapy.
Detailed description
In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.5 factors included positive iliac lymph nodes, histological type, tumor size, positive pelvic lymph nodes on both sides, and maximum lymph node diameter greater than 1cm. Different factors give different scores.If the score is higher than 3, the probability of retroperitoneal lymph node metastasis in patients with locally advanced cervical cancer is significantly increased, and the prognosis of patients is affected. Patients with locally advanced cervix receiving radical radiotherapy were scored based on 5 factors.Patients with scores greater than or equal to 3 points were compared with patients with scores less than 3 points.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scores greater than or equal to 3 in patients with locally advanced cervical cancer | – | –Scores greater than or equal to 3 in patients with locally advanced cervical cancer |
| Patients with locally advanced cervical cancer scored less than 3 points | – | –Patients receiving radiotherapy for locally advanced cervical cancer were scored according to five factors, with a score of less than 3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From May 2016 to July 2021, 183 patients with locally advanced cervical cancer received radiotherapy in our hospital ,with or without chemotherapy.Patients were scored according to 5 factors. PFS were compared between patients with scores greater than or equal to 3 points and those with scores less than 3 points. PFS is defined as the time from the end of treatment to disease progression or the time of the last follow-up 2022-10-01.
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
Progression Free Survival（PFS）
Time frame: 3 months
Whether there are differences in PFS between the two groups
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 22 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Zou Dongling, M.D. study director
Chongqing University Cancer Hospital Chongqing, Chongqing, China,
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 and Radiotherapy, run by Chongqing University Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Mar 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 China. 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?
Progression Free Survival（PFS） (time frame: 3 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 22 Mar 2023.