Cervix CarcinomaNCT06039982
A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer
An observational study of Cervix Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervix Carcinoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2026
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: we collect the medical data of cervical cancer patients in Fujian Cancer Hospital. All patients received a standardized staging evaluation before radical hysterectomy with bilateral pelvic lymphadenectomy, preoperative laboratory tests, abdominal MRI/CT, and thoracic CT.
Who may be able to join
- Pathologically confirmed cervical cancer;
- FIGO2018 stage IB-IIA according to the result of physical examination and images;
- No preoperative treatment before surgery;
- Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery.
- All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection.
Who cannot join
- Accompanied with other tumors;
- Accompanied with chronic infectious and immune diseases;
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yang Sun, 15959028989, sunyang@fjzlhospital.com
About this study
Official title: Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients
This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.
Read the detailed description
Vaginal invasion is a crucial index participant in cervical cancer tumor staging and prognosis prediction. However, the roles of vaginal invasion are overlooked in the literature, compared with those of lymph node metastasis and parametrial invasion. As far as we know, this study is novel to construct a nomogram to predict the probability of pathologic vaginal invasion occurrence.
- Conditions
- Cervix Carcinoma
- Being tested
- no intervention
- 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.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| cervical cancer treated with surgery | The inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal invasion
100 cervical cancer patients who underwent radical hysterectomy (RH) with bilateral pelvic lymphadenectomy were pathologically assessed for vaginal invasion. The primary outcome is vaginal invasion or no-vaginal invasion. Pathological vaginal invasion is defined as cervix tumor disruption of the vaginal wall.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervix CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039982
- Sponsor's protocol ID
- Yang Sun
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salvo G, Odetto D, Saez Perrotta MC, Noll F, Perrotta M, Pareja R, Wernicke A, Ramirez PT. Measurement of tumor size in early cervical cancer: an ever-evolving paradigm. Int J Gynecol Cancer. 2020 Aug;30(8):1215-1223. doi: 10.1136/ijgc-2020-001436. Epub 2020 Jul 6.
PubMed 32636272Thomeer MG, Gerestein C, Spronk S, van Doorn HC, van der Ham E, Hunink MG. Clinical examination versus magnetic resonance imaging in the pretreatment staging of cervical carcinoma: systematic review and meta-analysis. Eur Radiol. 2013 Jul;23(7):2005-18. doi: 10.1007/s00330-013-2783-4. Epub 2013 Mar 1.
PubMed 23455762Wagner-Larsen KS, Lura N, Salvesen O, Halle MK, Forsse D, Trovik J, Smit N, Krakstad C, Haldorsen IS. Interobserver agreement and prognostic impact for MRI-based 2018 FIGO staging parameters in uterine cervical cancer. Eur Radiol. 2022 Sep;32(9):6444-6455. doi: 10.1007/s00330-022-08666-x. Epub 2022 Mar 24.
PubMed 35332408
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT06039982
- Acronym / sponsor ID
- Yang Sun
- Conditions
- Cervix Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 Sep 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.
This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.
Detailed description
Vaginal invasion is a crucial index participant in cervical cancer tumor staging and prognosis prediction. However, the roles of vaginal invasion are overlooked in the literature, compared with those of lymph node metastasis and parametrial invasion. As far as we know, this study is novel to construct a nomogram to predict the probability of pathologic vaginal invasion occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervical cancer treated with surgery | – | Other: no interventionThe inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- we collect the medical data of cervical cancer patients in Fujian Cancer Hospital. All patients received a standardized staging evaluation before radical hysterectomy with bilateral pelvic lymphadenectomy, preoperative laboratory tests, abdominal MRI/CT, and thoracic CT.
Key inclusion criteria (5 listed)
- Pathologically confirmed cervical cancer;
- FIGO2018 stage IB-IIA according to the result of physical examination and images;
- No preoperative treatment before surgery;
- Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery.
- All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection.
Key exclusion criteria (3 listed)
- Accompanied with other tumors;
- Accompanied with chronic infectious and immune diseases;
- Incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | cervical cancer treated with surgery |
Primary outcome
vaginal invasion
Time frame: 7 days after surgery
100 cervical cancer patients who underwent radical hysterectomy (RH) with bilateral pelvic lymphadenectomy were pathologically assessed for vaginal invasion. The primary outcome is vaginal invasion or no-vaginal invasion. Pathological vaginal invasion is defined as cervix tumor disruption of the vaginal wall.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 32636272Salvo G, Odetto D, Saez Perrotta MC, Noll F, Perrotta M, Pareja R, Wernicke A, Ramirez PT. Measurement of tumor size in early cervical cancer: an ever-evolving paradigm. Int J Gynecol Cancer. 2020 Aug;30(8):1215-1223. doi: 10.1136/ijgc-2020-001436. Epub 2020 Jul 6.
- Background: PubMed 23455762Thomeer MG, Gerestein C, Spronk S, van Doorn HC, van der Ham E, Hunink MG. Clinical examination versus magnetic resonance imaging in the pretreatment staging of cervical carcinoma: systematic review and meta-analysis. Eur Radiol. 2013 Jul;23(7):2005-18. doi: 10.1007/s00330-013-2783-4. Epub 2013 Mar 1.
- Background: PubMed 35332408Wagner-Larsen KS, Lura N, Salvesen O, Halle MK, Forsse D, Trovik J, Smit N, Krakstad C, Haldorsen IS. Interobserver agreement and prognostic impact for MRI-based 2018 FIGO staging parameters in uterine cervical cancer. Eur Radiol. 2022 Sep;32(9):6444-6455. doi: 10.1007/s00330-022-08666-x. Epub 2022 Mar 24.
- 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.
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 Cervix Carcinoma, run by Fujian 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?
The sponsor lists 5 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: status not confirmed, as of the sponsor's last update on 26 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Sun, PHD (+8615959028989, sunyang@fjzlhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal invasion (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039982, which also lists 3 linked publications.
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 26 Sep 2023.