Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients
NCT ID: NCT06016868
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2023-08-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Interventional
Tumor tissue
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.
Blood sample
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.
Interventions
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Tumor tissue
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.
Blood sample
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Locations
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Policlinico Universitario Agostino Gemelli, IRCCS
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5773
Identifier Type: -
Identifier Source: org_study_id
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