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Trial Title:
Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients
NCT ID:
NCT06016868
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor tissue
Description:
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.
Arm group label:
Interventional
Intervention type:
Procedure
Intervention name:
Blood sample
Description:
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.
Arm group label:
Interventional
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.
Detailed description:
The importance of radioresistance in cervical cancer treatment failure indicates that
certain biomarkers may be useful for cervical cancer treatment individualization. Several
biomarkers of cervical cancer radioresistance have been previously studied and proposed;
however, none of these has been the subject to further clinical studies and implemented
into clinical practice. Recently, a panel of three protein coding genes
(ANXA2-NDRG1-STAT1) differently expressed in radiosensitive LACC patients compared with
the radioresistant ones, has been proposed by our institution. The population of LACC
patients included in a previous study was treated with neo-adjuvant CTRT followed by
radical surgery. 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.
Criteria for eligibility:
Study pop:
Patients with histologically-confirmed squamous cell carcinoma, adenocarcinoma, or
adenosquamous carcinoma of the cervix FIGO stage IIB and IIIC1.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Policlinico Universitario Agostino Gemelli, IRCCS
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Gabriella F Ferrandina, PhD
Phone:
0630158667
Email:
mariagabriella.ferrandina@policlinicogemelli.it
Start date:
August 1, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06016868
