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Not yet recruiting NCT06039982

A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

Observational Cervix Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention.
Who it may be relevant to
Registry conditions: Cervix Carcinoma. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients

Overview

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.

Interventions

  • Other no intervention
    no intervention

Primary outcome measures

  • vaginal invasion [Time frame: 7 days after surgery]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fujian Cancer Hospital — Fuzhou

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. PMID 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. PMID 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. PMID 35332408

Identifiers

NCT: NCT06039982 · Yang Sun

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗