Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients

NCT06016868 | Unknown

• 1 other identifier: 5773
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• To test the performance of the molecular signature.

  To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.

  60 months

Study Arms (1)

Interventional

Procedure: Tumor tissue; Procedure: Blood sample

Interventions

Tumor tissue PROCEDURE

Each newly diagnosed patient with LACC who meets the inclusion criteria will undergo cervical cancer biopsy either during the outpatient clinical examination or during examination during anesthetic. Part of the biopsy will be sent for histopathological analysis, while the remaining tissue will be embedded in OCT compound and immediately frozen at -80°C prior to transfer to biobank for subsequent analysis.

Interventional

Blood sample PROCEDURE

Every patient will undergo a peripheral venous blood sample which will be processed to analyze the presence of the proteins codified by three RNA species (ANXA2-NDRG1-STAT1). This blood sample will be performed before starting the treatment with exclusive CTRT.

Interventional

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix FIGO stage IIB and IIIC1.

You may qualify if:

• Age \> 18 years
• Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
• FIGO 2018 stage IIB and IIIC1\[38\]
• Treatment with exclusive chemoradiation including brachytherapy
• Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
• Has radiographically evaluable disease, measurable per RECIST 1.1
• Negative pregnancy test
• Adequate hematologic, renal, and hepatic functions, with following blood tests:
• Neutrophils \> 1500/μL Platelets \> 100.000/ μL Hemoglobin \> 9 g/dL Serum creatinine \< 1.8 mg/dL Total bilirubin \< 3 mg/ dL LDH \< 3x normal value GOT \< 3x normal value GPT \< 3x normal value ALP \< 3 x normal value

You may not qualify if:

• Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
• Neo-adjuvant treatment
• Patients included in other clinical trials
• Patients refusing to sign informed consent
• Contraindications to radiotherapy
• Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli, IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Gabriella Maria F Ferrandina, PhD

CONTACT

0630158667; mariagabriella.ferrandina@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 30, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)