Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04067882
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2019-08-22
Brief Title:
Validation of the Genetic Signature 354849 as a Prognostic Method
Sponsor:
National Institute of Cancerología
Organization:
National Institute of Cancerología
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 manufacturers recommendations The RNA will be stored at -20C 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
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 manufacturers recommendations The RNA will be stored at -20C 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None