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A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT06039982
Recruitment Status : Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Cervix Carcinoma Other: no intervention

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
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients
Estimated Study Start Date : November 1, 2023
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
no intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039982


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

Locations
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China, Fujian
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Contact: Yang Sun    15959028989    sunyang@fjzlhospital.com   
Sponsors and Collaborators
Fujian Cancer Hospital
More Information
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Publications:

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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT06039982    
Other Study ID Numbers: Yang Sun
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases