Clinical trial NCT06039982: A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer
Official title: Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervix Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

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.

Primary outcomes:
measure: vaginal invasion
timeFrame: 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.