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NCT04087785 Clinical Trial

microRNA Profile in Early-stage Cervical Cancer

Cervical Cancer Clinical Trial

Official title:
microRNA Profile Associated With Positive Lymph Node Metastasis in Early-stage Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04087785
Other study ID # Rev/06/15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2006
Est. completion date September 30, 2013

Study information
Verified date September 2019
Source National Institute of Cancerología
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Persistent infections with high-risk subtypes of the human papillomavirus (HPV) are recognized as the etiological factor for developing cervical cancer. The aim od this study was to identify a miRNA profile in patients with early-stage cervical cancer with positive lymph node metastasis treated. Formalin-fixed paraffin-embedded (FFPE) tissue samples of patients with a diagnosis of early-stage cervical cancer treated by radical hysterectomy with lymphadenectomy were collected.

Description:

Cervical carcinoma (CC) is one of the most common cancers in women from countries with emerging economies; in Mexico, CC has the second highest incidence and mortality rate. Several studies have demonstrated that the most important prognostic factor is lymph node metastasis in early-stage CC patients prior to radical hysterectomy (RH) with bilateral pelvic lymphadenectomy (BPL), in which positive lymph node metastasis decreasing overall survival (OS) from 80% to 53% at 5 years.

MicroRNAs (miRNAs) are single-strand RNAs comprising approximately 21-23 nucleotides. miRNAs regulate gene expression through the inhibition of posttranscriptional events and, in some cases, induce the degradation of their target messenger RNA. In cancer, miRNAs can function as both oncogenes and/or as tumor suppressor genes depending on the function of their target genes.

Formalin-fixed paraffin-embedded (FFPE) tissue blocks from CC patients diagnosed between January 2006 and December 2013 at the Department of Oncologic Gynecology of the National Cancer Institute (Mexico City) were analyzed with the intention of selecting those with a confirmed histopathological diagnosis of stages IB1 or IIA1 CC treated with RH and BPL. Total RNA was extracted from 5 (10-µm) sections for selected tissues.For the clinical correlation analysis, the samples were divided into 2 groups: 1 with positive occult lymph node metastasis pathology and 1 without lymph node metastasis pathology. For both groups, patients were matched for age, tumor size and presence of lymphovascular permeation.

The identification of global miRNA profiles was performed using GeneChip miRNA 3.0 Array (Affymetrix, Cat. 902018) following the manufacturer's instructions. the microarray was hybridized and washed using the Affymetrix Fluidics Station 450 and scanned with the Affymetrix GeneChip Scanner 3000. After processing the images, the raw data were processed. To obtain the miRNA profile, the processed samples were divided into 2 groups, samples with lymph node metastasis and samples without lymph node metastasis. Differentially expressed miRNAs were identified using a cutoff value of p <0.01 and a fold change (FC) of 1.5. miRNAs that met these criteria were classified as over-expressed or under-expressed.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date September 30, 2013
Est. primary completion date September 30, 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cervical cancer histopathological diagnosis

- Clinical stage IB1 or IIA1 CC

- Treated with radical hysterectomy (RH) with bilateral pelvic lymphadenectomy (BPL)

Exclusion Criteria:

- Double primary tumors

- Treatment regimens other than standard treatment

- Poor quality formalin-fixed paraffin-embedded tissue blocks

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Cancerología

References & Publications (10)

Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. Review. — View Citation

Delgado G, Bundy B, Zaino R, Sevin BU, Creasman WT, Major F. Prospective surgical-pathological study of disease-free interval in patients with stage IB squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 1990 Sep;38(3):352-7. — View Citation

Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Chan J, Cho KR, Cohn D, Crispens MA, DuPont N, Eifel PJ, Gaffney DK, Giuntoli RL 2nd, Han E, Huh WK, Lurain JR 3rd, Martin L, Morgan MA, Mutch D, Remmenga SW, Reynolds RK, Small W Jr, Teng N, Tillmanns T, Valea FA, McMillian NR, Hughes M; National Comprehensive Cancer Network. Cervical cancer. J Natl Compr Canc Netw. 2013 Mar 1;11(3):320-43. — View Citation

Lea JS, Lin KY. Cervical cancer. Obstet Gynecol Clin North Am. 2012 Jun;39(2):233-53. doi: 10.1016/j.ogc.2012.02.008. Epub 2012 Apr 24. — View Citation

Lee JW, Choi CH, Choi JJ, Park YA, Kim SJ, Hwang SY, Kim WY, Kim TJ, Lee JH, Kim BG, Bae DS. Altered MicroRNA expression in cervical carcinomas. Clin Cancer Res. 2008 May 1;14(9):2535-42. doi: 10.1158/1078-0432.CCR-07-1231. — View Citation

Pedroza-Torres A, López-Urrutia E, García-Castillo V, Jacobo-Herrera N, Herrera LA, Peralta-Zaragoza O, López-Camarillo C, De Leon DC, Fernández-Retana J, Cerna-Cortés JF, Pérez-Plasencia C. MicroRNAs in cervical cancer: evidences for a miRNA profile deregulated by HPV and its impact on radio-resistance. Molecules. 2014 May 16;19(5):6263-81. doi: 10.3390/molecules19056263. Review. — View Citation

Suprasert P, Charoenkwan K, Khunamornpong S. Pelvic node removal and disease-free survival in cervical cancer patients treated with radical hysterectomy and pelvic lymphadenectomy. Int J Gynaecol Obstet. 2012 Jan;116(1):43-6. doi: 10.1016/j.ijgo.2011.08.001. Epub 2011 Oct 5. — View Citation

Tanaka Y, Sawada S, Murata T. Relationship between lymph node metastases and prognosis in patients irradiated postoperatively for carcinoma of the uterine cervix. Acta Radiol Oncol. 1984;23(6):455-9. — View Citation

Thomison J 3rd, Thomas LK, Shroyer KR. Human papillomavirus: molecular and cytologic/histologic aspects related to cervical intraepithelial neoplasia and carcinoma. Hum Pathol. 2008 Feb;39(2):154-66. doi: 10.1016/j.humpath.2007.11.002. Review. — View Citation

Togami S, Kamio M, Yanazume S, Yoshinaga M, Douchi T. Can pelvic lymphadenectomy be omitted in stage IA2 to IIB uterine cervical cancer? Int J Gynecol Cancer. 2014 Jul;24(6):1072-6. doi: 10.1097/IGC.0000000000000163. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prognostic miRNAs Identify a subset of miRNAs with prognostic value associated with early-stage CC patients treated with RH and BPL with positive lymph node metastasis. 7 years
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