Prognostic Value of Protein IMP3 Expression in Cervical Cancer

NCT05151159 | Completed

• 1 other identifier: IMP3, cervical cancer
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The results of recent research on cervical cancer and its precancerous lesions have linked the expression of IMP3 protein to cervical dysplasia and the possibility of severe cervical dysplasia (CIN III) progressing to squamous cell carcinoma. A higher expression of IMP3 protein was found in the cytoplasms of severe cervical dysplasia (CIN III) cells and invasive tumor cells compared to CIN I and CIN II change cells. The sensitivity of IMP3 expression in tumor cells was 96%. In preparations that were IMP3 negative, no further monitoring and treatment revealed squamous cell carcinoma. Further analyzes indicated the possibility of determining IMP3 expression on first cervical biopsy specimens in patients with HSIL ( high grade squamous intraepithelial lesion) lesions as a biomarker to detect a subset of patients in whom lesion invasiveness can be expected.

Conditions

Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• High expression of IMP3 protein in cervical squamous cell carcinoma is associated with a poorer disease outcome.

  Investigators are about to examine the association between IMP3 protein expression and disease spread according to the FIGO classification (clinical-pathological grading of the disease)

  10 Years ( 2003-2013)

Study Arms (4)

FIGO group 1A1

20 subjects with tumor invasion depth up to 1 mm

Other: immunohistochemical analysis with murine monoclonal antihuman antibodies IMP3

FIGO group 1A2

20 subjects with an invasion depth of 1 - 3 mm

Other: immunohistochemical analysis with murine monoclonal antihuman antibodies IMP3

FIGO group 1B1

20 subjects with invasion depth up to 2 cm

Other: immunohistochemical analysis with murine monoclonal antihuman antibodies IMP3

FIGO group 1B2

20 subjects with tumor invasion depth\> 2 cm 20 subjects with tumor invasion depth\> 2 cm

Other: immunohistochemical analysis with murine monoclonal antihuman antibodies IMP3

Interventions

immunohistochemical analysis with murine monoclonal antihuman antibodies IMP3 OTHER

FIGO group 1A1; FIGO group 1A2; FIGO group 1B1; FIGO group 1B2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Operated women in University Clinic Mostar, who were diagnosed with squamous cell carcinoma cervicis in period of January 2003 to Decembar 2013.

You may qualify if:

• operated women diagnosed with squamous cell carcinoma of the cervix at the figo stage 1a1, 1a2, 1b1 and 1b2

You may not qualify if:

• patients who underwent preoperative chemo and / or radiotherapy
• patients with associated gynecological or other malignant diseases
• patients with other histological types of tumors (adenocarcinoma, adenosquamous, neuroendocrine, etc.)

Sponsors & Collaborators

• University of Mostar: lead

Biospecimen

Retention: SAMPLES WITH DNA

Parts of cervix

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Krešić Tanja, Mr.sc

  University Mostar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.sc. Tanja Krešić, ob/gyn specialist, gyn oncology subspecialist

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 9, 2021
• Study Start: January 1, 2003
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning by three months and ending 5 Years following article publication.
• Access Criteria: Investigators whose proposed use the Data has been approved by an Independent Review committe identified for this purpose.