Clinical trial NCT04087785: microRNA Profile in Early-stage Cervical Cancer
Official title: microRNA Profile Associated With Positive Lymph Node Metastasis in Early-stage Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: miRNAs
cervical cancer
lymph node metastasis
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2019-09-12
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cervical cancer between January 2006 and December 2013 at the Department of Oncologic Gynecology of the National Cancer Institute (Mexico City).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prognostic miRNAs
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute of Mexico
name: David F Cantú-deLeón, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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