Validation of the Genetic Signature 354849 as a Prognostic Method
- Conditions
- Cervix Cancer
- Interventions
- Other: Genetic signature
- Registration Number
- NCT04067882
- Lead Sponsor
- National Institute of Cancerología
- Brief Summary
This prospective study is focused on the validation of the genetic signature of 27 genes as a predictor of the response to concomitant chemotherapy treatment followed by brachytherapy in patients with locally advanced cervical cancer. The genes included are: ZNF238; SAP30; C10orf137; UHRF1; SUZ12; HMGN4; RBBP4; PPP1CB; SLFN11; FLJ39378; ENDOGL1; RECQL; TRPC1; TRIO; DNAH6; GNL3L; SLC36A2; SRP9; RPE; LDOC1L; PUS7L; CCDC89; LOC644921; PLEKHG1; FAM111B; RPRD2 y ETAA16.
- Detailed Description
There are several studies of genes or genetic signatures associated with the response to treatment in cervical cancer, but so far it has not been possible to standardize the use of any biomarker or biomarker signature as a predictor of the response to treatment with reproducible results. Therefore, there is still a need to develop an effective method to predict the response to chemo-radiotherapy in locally advanced cervical cancer. This prospective study included 189 patients with cervical cancer clinical stages IB2-IVA, without previous treatment.
Tumor samples will be obtained at the confirmatory diagnostic biopsy. All samples will be processed by the pathology laboratory as usual. The RNA will be extracted from the paraffin blocks with the RNeasy FFPE Kit (Qiagen) according to the manufacturer's recommendations. The RNA will be stored at -20°C until use. Quantitative PCR (qPCR) will be performed with the kit High-Capacity cDNA Reverse transcription Kit (Thermo Fisher Scientific). Primers for the 27 genes will be developed. The relative expression will be calculated using the 2- ΔΔCt method, using the expression of β-actin as a normalizing gene.
In order to obtain the prognostic score, the score assigned by the classifier for the sample will be calculated from the 2-ΔΔCt values obtained for each gene. This will be done by a computer-readable medium containing the type expression profiles related to a good and a bad response to the standard treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 189
- Women over 18 years old
- Cervical Cancer at IB2-IVA FIGO´s clinical stages
- Histology: squamous, adenosquamous or adenocarcinoma
- No previous treatment
- No distance metastases, discard by PET/CT
- Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
- Candidates to receive standard chemoradiotherapy treatment followed by brachytherapy
- Previous chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
- Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum.
- Previous systemic chemotherapy for the current cervical cancer.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cervix cancer Genetic signature Women older than 18 years with histopathological diagnosis of cervical cancer clinical stage I2-IVA, candidates to receive standard treatment with chemotherapy followed by brachytherapy.
- Primary Outcome Measures
Name Time Method Genetic signature validation 2 years Validate the genetic signature of 27 genes to predict treatment response in patients with cervix cancer.
- Secondary Outcome Measures
Name Time Method Predictive values test 2 years Determine sensitivity, specificity and predictive values.
Trial Locations
- Locations (2)
Instituto Nacional de Cancerologia
🇲🇽Mexico, Mexico City, Mexico
David Cantu de Leon
🇲🇽Mexico City, Tlalpan, Mexico