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Cervical CancerNCT04087785

microRNA Profile in Early-stage Cervical Cancer

An observational study of Cervical Cancer, run by National Institute of Cancerología.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
How many people
44 participants
Where
No sites listed yet
Study dates
1 Sep 2006to 30 Sep 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • Cervical cancer histopathological diagnosis
  • Clinical stage IB1 or IIA1 CC
  • Treated with radical hysterectomy (RH) with bilateral pelvic lymphadenectomy (BPL)

Who cannot join

  • Double primary tumors
  • Treatment regimens other than standard treatment
  • Poor quality formalin-fixed paraffin-embedded tissue blocks

About this study

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

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.

Read the 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.

Conditions
Cervical Cancer
Keywords
miRNAs, cervical cancer, lymph node metastasis
Medical subject headings
Uterine Cervical Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04087785
Study groupRoleWhat they receive
Positive metastasisPositive occult lymph node metastasis pathology
Negative metastasisWithout lymph node metastasis pathology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start1 Sep 2006
  3. Primary completion30 Sep 2013
  4. Study completion30 Sep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087785
Sponsor's protocol ID
Rev/06/15
Status last verified
Sep 2019
First submitted
11 Sep 2019
Last updated
13 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18206494

  • 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. doi: 10.6004/jnccn.2013.0043.

    PubMed 23486458

  • 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.

    PubMed 22640713

  • 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. doi: 10.1016/0090-8258(90)90072-s.

    PubMed 2227547

  • 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.

    PubMed 21978816

  • 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.

    PubMed 24905616

  • 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. doi: 10.3109/02841868409136048.

    PubMed 6099039

  • Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.

    PubMed 14744438

  • Pedroza-Torres A, Lopez-Urrutia E, Garcia-Castillo V, Jacobo-Herrera N, Herrera LA, Peralta-Zaragoza O, Lopez-Camarillo C, De Leon DC, Fernandez-Retana J, Cerna-Cortes JF, Perez-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.

    PubMed 24840898

  • 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.

    PubMed 18451214

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer, run by National Institute of Cancerología.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic miRNAs (time frame: 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04087785, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.

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