NCT04087785

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2013

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

7.1 years

First QC Date

September 11, 2019

Last Update Submit

September 11, 2019

Conditions

Cervical Cancer

Keywords

miRNAscervical cancerlymph node metastasis

Outcome Measures

Primary Outcomes (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.

    7 years

Study Arms (2)

Positive metastasis

Positive occult lymph node metastasis pathology

Negative metastasis

Without lymph node metastasis pathology

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 18206494BACKGROUND

  • 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.

    PMID: 23486458BACKGROUND

  • 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.

    PMID: 22640713BACKGROUND

  • 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.

    PMID: 2227547BACKGROUND

  • 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.

    PMID: 21978816BACKGROUND

  • 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.

    PMID: 24905616BACKGROUND

  • 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.

    PMID: 6099039BACKGROUND

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

    PMID: 14744438BACKGROUND

  • 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.

    PMID: 24840898BACKGROUND

  • 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.

    PMID: 18451214BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded tissue blocks.

MeSH Terms

Conditions

Uterine Cervical NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David F Cantú-deLeón, MD, PhD

    National Cancer Institute of Mexico

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

September 1, 2006

Primary Completion

September 30, 2013

Study Completion

September 30, 2013

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share