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Validation of the Genetic Signature 354849 as a Prognostic Method

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ClinicalTrials.gov Identifier: NCT04067882
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
David Cantu, National Institute of Cancerología

Tracking Information
First Submitted Date August 22, 2019
First Posted Date August 28, 2019
Last Update Posted Date August 28, 2019
Estimated Study Start Date September 30, 2019
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2019)
Genetic signature validation [ Time Frame: 2 years ]
Validate the genetic signature of 27 genes to predict treatment response in patients with cervix cancer.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 23, 2019)
Predictive values test [ Time Frame: 2 years ]
Determine sensitivity, specificity and predictive values.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of the Genetic Signature 354849 as a Prognostic Method
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor samples will be collected during the diagnostic biopsy and will be routinely processed by the pathology laboratory.
Sampling Method Probability Sample
Study Population Patients with the histopathological diagnosis of cervical cancer FIGO's clinical stage IB2-IVA.
Condition Cervix Cancer
Intervention 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.
Study Groups/Cohorts Cervix cancer
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.
Intervention: Other: Genetic signature
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 23, 2019)
189
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: David F Cantú-de León, MD, MSc. PhD +5215537093156 dfcantu@gmail.com
Contact: Carlos G Pérez-Placencia, MSc, PhD car_plas@yahoo.com
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT04067882
Other Study ID Numbers 019/018/ICI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 2 years
Access Criteria: the data will be shared with scientific and academic institutions or research groups that study the same topic and with the regulatory and ethical authorities that require it, to ensure the quality and accuracy of the data.
Responsible Party David Cantu, National Institute of Cancerología
Study Sponsor National Institute of Cancerología
Collaborators Not Provided
Investigators
Principal Investigator: David F Cantú-deLeón, MD, PhD National Cancer Institute of Mexico
PRS Account National Institute of Cancerología
Verification Date August 2019