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Not yet recruitingNCT06039982Updated Sep 26, 2023

A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

An observational study in Cervix Carcinoma, sponsored by Fujian Cancer Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Fujian Cancer Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Cervix Carcinoma
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 100 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Accompanied with other tumors;
  • Accompanied with chronic infectious and immune diseases;
  • Incomplete clinical data.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days after surgery

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Study locations

1 site
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References and documents

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 32636272 ↗
  • Thomeer 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 23455762 ↗
  • Wagner-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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06039982
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Sep 26, 2023

Study contacts

Yang Sun, PHD
Contact
sunyang@fjzlhospital.com
+8615959028989

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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