Validation of the Genetic Signature 354849 as a Prognostic Method
NCT ID: NCT04067882
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
189 participants
OBSERVATIONAL
2019-09-30
2024-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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National Institute of Cancerología
OTHER_GOV
Responsible Party
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David Cantu
Chief of clinical trials department
Principal Investigators
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David F Cantú-deLeón, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute of Mexico
Locations
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Instituto Nacional de Cancerologia
Mexico City, Mexico City, Mexico
David Cantu de Leon
Mexico City, Tlalpan, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Crosbie EJ, Einstein MH, Franceschi S, Kitchener HC. Human papillomavirus and cervical cancer. Lancet. 2013 Sep 7;382(9895):889-99. doi: 10.1016/S0140-6736(13)60022-7. Epub 2013 Apr 23.
Cohen PA, Jhingran A, Oaknin A, Denny L. Cervical cancer. Lancet. 2019 Jan 12;393(10167):169-182. doi: 10.1016/S0140-6736(18)32470-X.
Bhatla N, Aoki D, Sharma DN, Sankaranarayanan R. Cancer of the cervix uteri. Int J Gynaecol Obstet. 2018 Oct;143 Suppl 2:22-36. doi: 10.1002/ijgo.12611.
Todo Y, Watari H. Concurrent chemoradiotherapy for cervical cancer: background including evidence-based data, pitfalls of the data, limitation of treatment in certain groups. Chin J Cancer Res. 2016 Apr;28(2):221-7. doi: 10.21147/j.issn.1000-9604.2016.02.10.
Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
Leath CA 3rd, Monk BJ. Twenty-first century cervical cancer management: A historical perspective of the gynecologic oncology group/NRG oncology over the past twenty years. Gynecol Oncol. 2018 Sep;150(3):391-397. doi: 10.1016/j.ygyno.2018.06.023. Epub 2018 Jun 27.
Thomas GM. Improved treatment for cervical cancer--concurrent chemotherapy and radiotherapy. N Engl J Med. 1999 Apr 15;340(15):1198-200. doi: 10.1056/NEJM199904153401509. No abstract available.
Lakosi F, de Cuypere M, Viet Nguyen P, Jansen N, Warlimont B, Gulyban A, Gennigens C, Seidel L, Delbecque K, Coucke P, Hermesse J, Kridelka F. Clinical efficacy and toxicity of radio-chemotherapy and magnetic resonance imaging-guided brachytherapy for locally advanced cervical cancer patients: A mono-institutional experience. Acta Oncol. 2015;54(9):1558-66. doi: 10.3109/0284186X.2015.1062542. Epub 2015 Sep 25.
Chuang L, Kanis MJ, Miller B, Wright J, Small W Jr, Creasman W. Treating Locally Advanced Cervical Cancer With Concurrent Chemoradiation Without Brachytherapy in Low-resource Countries. Am J Clin Oncol. 2016 Feb;39(1):92-7. doi: 10.1097/COC.0000000000000222.
Chemoradiotherapy for Cervical Cancer Meta-analysis Collaboration (CCCMAC). Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: individual patient data meta-analysis. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD008285. doi: 10.1002/14651858.CD008285.
Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.
Marita A, Ordeanu C, Rancea A, Nicolae T, Nagy VM. Long-term survival following neoadjuvant chemotherapy and concomitant radiochemotherapy in locally advanced cervical cancer: results of the Oncology Institute "Prof. Dr. Ion Chiricuta" experience. J Med Life. 2018 Jan-Mar;11(1):42-50.
Yin KC, Lu CH, Lin JC, Hsu CY, Wang L. Treatment outcomes of locally advanced cervical cancer by histopathological types in a single institution: A propensity score matching study. J Formos Med Assoc. 2018 Oct;117(10):922-931. doi: 10.1016/j.jfma.2018.07.002. Epub 2018 Jul 17.
Horikawa N, Baba T, Matsumura N, Murakami R, Abiko K, Hamanishi J, Yamaguchi K, Koshiyama M, Yoshioka Y, Konishi I. Genomic profile predicts the efficacy of neoadjuvant chemotherapy for cervical cancer patients. BMC Cancer. 2015 Oct 19;15:739. doi: 10.1186/s12885-015-1703-1.
Moreno-Acosta P, Carrillo S, Gamboa O, Romero-Rojas A, Acosta J, Molano M, Balart-Serra J, Cotes M, Rancoule C, Magne N. Novel predictive biomarkers for cervical cancer prognosis. Mol Clin Oncol. 2016 Dec;5(6):792-796. doi: 10.3892/mco.2016.1055. Epub 2016 Oct 19.
Chen Q, Tian WJ, Huang ML, Liu CH, Yao TT, Guan MM. Association Between HIF-1 Alpha Gene Polymorphisms and Response in Patients Undergoing Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer. Med Sci Monit. 2016 Sep 5;22:3140-6. doi: 10.12659/msm.897486.
Fernandez-Retana J, Lasa-Gonsebatt F, Lopez-Urrutia E, Coronel-Martinez J, Cantu De Leon D, Jacobo-Herrera N, Peralta-Zaragoza O, Perez-Montiel D, Reynoso-Noveron N, Vazquez-Romo R, Perez-Plasencia C. Transcript profiling distinguishes complete treatment responders with locally advanced cervical cancer. Transl Oncol. 2015 Apr;8(2):77-84. doi: 10.1016/j.tranon.2015.01.003.
Zwenger AO, Grosman G, Iturbe J, Leone J, Vallejo CT, Leone JP, Verdera PP, Perez JE, Leone BA. Expression of ERCC1 and TUBB3 in locally advanced cervical squamous cell cancer and its correlation with different therapeutic regimens. Int J Biol Markers. 2015 Jul 22;30(3):e301-14. doi: 10.5301/jbm.5000161.
Wen YF, Cheng TT, Chen XL, Huang WJ, Peng HH, Zhou TC, Lin XD, Zeng LS. Elevated circulating tumor cells and squamous cell carcinoma antigen levels predict poor survival for patients with locally advanced cervical cancer treated with radiotherapy. PLoS One. 2018 Oct 10;13(10):e0204334. doi: 10.1371/journal.pone.0204334. eCollection 2018.
Related Links
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Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, B.F. Global Cancer Observatory: Cancer Today
World Health Organitation. Human papillomavirus (HPV) and cervical cancer.
Other Identifiers
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019/018/ICI
Identifier Type: -
Identifier Source: org_study_id
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