Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-upNCT06480617
Observational, Bivariate Analysis of Clinical Big Data in Patients With Cervical Cancer
An observational study of Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up and Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This is a large non-interventional observational bidirectional study planned to collect clinically relevant data and prognostic follow-up information of patients with cervical cancer who were seen at our center from 2010.01.01 to the end of this study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up, Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Dec 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: Cervical cancer patients seen and treated at the Department of Gynaecological Oncology of the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)
Who may be able to join
- Age ≥ 18 years;
- patients with a clear pathological diagnosis of cervical cancer;
- all patients included in this study were diagnosed after 1 January 2010
- Diagnosis or treatment of cervical cancer at the centres covered by this study;
- exemption from informed consent or signing of an informed consent form.
Who cannot join
- Loss of contact during the follow-up period for no apparent reason;
- Discharged from the hospital for follow-up treatment at an outside institution with unknown treatment status;
- The investigator considers the patient unsuitable for participation in this study;
- cases where the clinical diagnosis is in doubt or unclear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
This is a large non-interventional observational bidirectional study planned to collect clinically relevant data and prognostic follow-up information of patients with cervical cancer who were seen at our center from 2010.01.01 to the end of this study.
Read the detailed description
This study is a large-scale observational, bi-directional analytical study, which collects clinical data from patients with cervical cancer who have received treatment in the Department of Gynecologic Oncology of the First Hospital Affiliated to the University of Science and Technology of China (Anhui Provincial Hospital), including age, weight, BMI, menopausal status, history of the current disease, past history, specialized examinations, results of tests, results of genetic testing, pathology-related data, and information related to surgery, etc. The diagnosis, subsequent treatment, and follow-up of the subjects follow the routine clinical procedures of the clinical center. The diagnosis and subsequent treatment and follow-up of the subjects followed the routine clinical procedures of the clinical center, and the follow-up data of the enrolled patients were collected every six months: imaging, tumor markers, recurrence and treatment. And clinical big data analysis. Therefore, patients who meet the enrollment criteria can be included, and the sample size is based on the actual number of cases included.
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 |
|---|---|---|
| LNM(+) | Postoperative pathology suggests lymph node metastasis | |
| LNM(-) | Postoperative pathology did not suggest lymph node metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 5 years
Secondary outcomes (1)
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start31 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-upStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yin Zhou, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480617
- Sponsor's protocol ID
- 2023-KY347
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
- ClinicalTrials.gov ID
- NCT06480617
- Acronym / sponsor ID
- 2023-KY347
- Conditions
- Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up, Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jun 2024 (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.
This is a large non-interventional observational bidirectional study planned to collect clinically relevant data and prognostic follow-up information of patients with cervical cancer who were seen at our center from 2010.01.01 to the end of this study.
Detailed description
This study is a large-scale observational, bi-directional analytical study, which collects clinical data from patients with cervical cancer who have received treatment in the Department of Gynecologic Oncology of the First Hospital Affiliated to the University of Science and Technology of China (Anhui Provincial Hospital), including age, weight, BMI, menopausal status, history of the current disease, past history, specialized examinations, results of tests, results of genetic testing, pathology-related data, and information related to surgery, etc. The diagnosis, subsequent treatment, and follow-up of the subjects follow the routine clinical procedures of the clinical center. The diagnosis and subsequent treatment and follow-up of the subjects followed the routine clinical procedures of the clinical center, and the follow-up data of the enrolled patients were collected every six months: imaging, tumor markers, recurrence and treatment. And clinical big data analysis. Therefore, patients who meet the enrollment criteria can be included, and the sample size is based on the actual number of cases included.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNM(+) | – | –Postoperative pathology suggests lymph node metastasis |
| LNM(-) | – | –Postoperative pathology did not suggest lymph node metastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cervical cancer patients seen and treated at the Department of Gynaecological Oncology of the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- patients with a clear pathological diagnosis of cervical cancer;
- all patients included in this study were diagnosed after 1 January 2010
- Diagnosis or treatment of cervical cancer at the centres covered by this study;
- exemption from informed consent or signing of an informed consent form.
Key exclusion criteria (4 listed)
- Loss of contact during the follow-up period for no apparent reason;
- Discharged from the hospital for follow-up treatment at an outside institution with unknown treatment status;
- The investigator considers the patient unsuitable for participation in this study;
- cases where the clinical diagnosis is in doubt or unclear.
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
Time frame: 5 years
1 secondary outcome
overall survival
Time frame: 5 years
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 28 Jun 2024.
- Individual participant dataSharing planned: No
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.
Yin Zhou, MD study chair
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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 Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up and Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up, run by Anhui Provincial 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?
The sponsor lists 5 inclusion and 4 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 28 Jun 2024. 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?
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?
progression-free survival (time frame: 5 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 28 Jun 2024.