Validation of the Genetic Signature 354849 as a Prognostic Method

NCT04067882 | Unknown

• 1 other identifier: 019/018/ICI
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervix Cancer

Keywords

Genetic signature; Treatment response

Outcome Measures

Primary Outcomes (1)

• Genetic signature validation

  Validate the genetic signature of 27 genes to predict treatment response in patients with cervix cancer.

  2 years

Secondary Outcomes (1)

• Predictive values test

  2 years

Study Arms (1)

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

Interventions

Genetic signature OTHER

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.

Cervix cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (2)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

RECRUITING

David Cantu de Leon

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Related Publications (19)

• 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.

  PMID: 23618600 BACKGROUND

• 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.

  PMID: 30638582 BACKGROUND

• 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.

  PMID: 30306584 BACKGROUND

• 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.

  PMID: 27199520 BACKGROUND

• 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.

  PMID: 10202164 BACKGROUND

• 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.

  PMID: 29954593 BACKGROUND

• 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.

  PMID: 10202172 BACKGROUND

• 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.

  PMID: 26406152 BACKGROUND

• 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.

  PMID: 26398064 BACKGROUND

• 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.

  PMID: 20091664 BACKGROUND

• 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.

  PMID: 19001332 BACKGROUND

• 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.

  PMID: 29696064 BACKGROUND

• 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.

  PMID: 30025761 BACKGROUND

• 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.

  PMID: 26482555 BACKGROUND

• 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.

  PMID: 28101358 BACKGROUND

• 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.

  PMID: 27593081 BACKGROUND

• 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.

  PMID: 25926073 BACKGROUND

• 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.

  PMID: 26165688 BACKGROUND

• 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.

  PMID: 30303986 BACKGROUND

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples will be collected during the diagnostic biopsy and will be routinely processed by the pathology laboratory.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• David F Cantú-deLeón, MD, PhD

  National Cancer Institute of Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David F Cantú-de León, MD, MSc. PhD

CONTACT

+5215537093156; dfcantu@gmail.com

Carlos G Pérez-Placencia, MSc, PhD

CONTACT

car_plas@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of clinical trials department

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 30, 2019
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

ME (2)