Validation of the Genetic Signature 354849 as a Prognostic Method
|ClinicalTrials.gov Identifier: NCT04067882|
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment|
|Cervix Cancer||Other: Genetic signature|
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.
|Study Type :||Observational|
|Estimated Enrollment :||189 participants|
|Official Title:||Prospective Study for the Validation of the Genetic Signature 354849 to Predict the Response to Standard Treatment in Patients With Locally Advanced Cervical Cancer|
|Estimated Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
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.
Other: Genetic signature
The RNA will be extracted from the tumor sample with a special kit and a q-PCR will be performed. In order to quantify the genetic expression, the comparative method called Cycle threshold or Crossing point will be used.
- Genetic signature validation [ Time Frame: 2 years ]Validate the genetic signature of 27 genes to predict treatment response in patients with cervix cancer.
- Predictive values test [ Time Frame: 2 years ]Determine sensitivity, specificity and predictive values.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067882
|Contact: David F Cantú-de León, MD, MSc. PhDfirstname.lastname@example.org|
|Contact: Carlos G Pérez-Placencia, MSc, PhDemail@example.com|
|David Cantu de Leon|
|Mexico City, Tlalpan, Mexico, 14080|
|Principal Investigator:||David F Cantú-deLeón, MD, PhD||National Cancer Institute of Mexico|