Validation of the Genetic Signature 354849 as a Prognostic Method

November 12, 2023 updated by: David Cantu, National Institute of Cancerología

Prospective Study for the Validation of the Genetic Signature 354849 to Predict the Response to Standard Treatment in Patients With Locally Advanced Cervical Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David F Cantú-de León, MD, MSc. PhD
  • Phone Number: +5215537093156
  • Email: dfcantu@gmail.com

Study Contact Backup

Study Locations

  • Mexico
    • Mexico City
      • Mexico, Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
        • Contact:
          • David F Cantu-de Leon, Md, PhD
          • Phone Number: 21016 525556280400
          • Email: dfcantu@gmail.com
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • David Cantu de Leon
        • Contact:
        • Contact:
          • David F Cantu-de Leon, MD. Msc. Phd
          • Phone Number: +5215537093116
          • Email: dfcantu@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with the histopathological diagnosis of cervical cancer FIGO's clinical stage IB2-IVA.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic signature validation
Time Frame: 2 years
Validate the genetic signature of 27 genes to predict treatment response in patients with cervix cancer.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive values test
Time Frame: 2 years
Determine sensitivity, specificity and predictive values.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cancerología

Investigators

  • Principal Investigator: David F Cantú-deLeón, MD, PhD, National Cancer Institute of Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019/018/ICI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

2 years

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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