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Validation of the Genetic Signature 354849 as a Prognostic Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04067882
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
David Cantu, 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.

Condition or disease Intervention/treatment
Cervix Cancer Other: Genetic signature

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.

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Study Type : Observational
Estimated Enrollment : 189 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.

Primary Outcome Measures :
  1. Genetic signature validation [ Time Frame: 2 years ]
    Validate the genetic signature of 27 genes to predict treatment response in patients with cervix cancer.

Secondary Outcome Measures :
  1. Predictive values test [ Time Frame: 2 years ]
    Determine sensitivity, specificity and predictive values.

Biospecimen Retention:   Samples With DNA
Tumor samples will be collected during the diagnostic biopsy and will be routinely processed by the pathology laboratory.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with the histopathological diagnosis of cervical cancer FIGO's clinical stage IB2-IVA.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04067882

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Contact: David F Cantú-de León, MD, MSc. PhD +5215537093156
Contact: Carlos G Pérez-Placencia, MSc, PhD

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David Cantu de Leon
Mexico City, Tlalpan, Mexico, 14080
Sponsors and Collaborators
National Institute of Cancerología
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Principal Investigator: David F Cantú-deLeón, MD, PhD National Cancer Institute of Mexico
Additional Information:

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Responsible Party: David Cantu, Chief of clinical trials department, National Institute of Cancerología Identifier: NCT04067882    
Other Study ID Numbers: 019/018/ICI
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Cantu, National Institute of Cancerología:
Genetic signature
Treatment response
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female