Adenocarcinoma of the Uterine Cervix and HPV

NCT05267834 | Completed

• 1 other identifier: AC-HPV2
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will mainly aim to review and characterize the pathologic features, treatment options, and follow-up outcomes of women with in situ/microinvasive adenocarcinoma of the uterine cervix according to HPV status (positive versus negative high-risk HPV). It will evaluate the impact of HPV status on the recurrence and survival during a follow-up of five years. The present study will be a multi-institutional study including several oncological Italian Centers. Data will be retrospectively collected from January 2012 to December 2016 with a total follow-up of 5 years.

Conditions

Adenocarcinoma of the Uterine Cervix

Keywords

Cervical Adenocarcinoma; HPV Type; Screening Program; Treatment; Recurrence; Survival; Follow-up

Outcome Measures

Primary Outcomes (2)

• Overall recurrence at 5 year in HPV positive vs HPV negative women

  Number of women who have recurrence after treatment divided by total number of patients at onset

  At 5 years

• Overall survival at 5 year in HPV positive vs HPV negative women

  Number of women who are alive after treatment divided by total number of patients at onset

  At 5 years

Secondary Outcomes (1)

• HPV-type disease recurrence at 5 years

  At 5 years

Study Arms (2)

Positive high-risk HPV

Women with adenocarcinoma of the uterine cervix and positive for high-risk HPV (genotype16/18/31/33/35/39/45/51/52/56/58/59/68).

Procedure: Conization and/or Hysterectomy

Negative high-risk HPV

Women with adenocarcinoma of the uterine cervix and negative for high-risk HPV (genotype16/18/31/33/35/39/45/51/52/56/58/59/68).

Procedure: Conization and/or Hysterectomy

Interventions

Conization and/or Hysterectomy PROCEDURE

Women undergoing cervical conization or simple/modified/radical hysterectomy with or without pelvic lymphadenectomy

Negative high-risk HPV; Positive high-risk HPV

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women who were diagnosed with in situ or microinvasive (stage 1 A) adenocarcinoma of the uterine cervix, and undergoing surgical treatment, between 2012 and 2016.

You may qualify if:

• Women with in-situ or microinvasive (stage 1A) adenocarcinoma of the uterine cervix undergoing conization or hysterectomy, between January 2012 and December 2016.
• Women with HPV testing within 2 months before conization.
• Women should be diagnosed and managed by the corresponding center.
• Patients with adequate clinical and pathological data.

You may not qualify if:

• Women with previous cervical treatments.
• Women with immunological disease (e.g. HIV).
• Unavailable HPV testing before surgery.
• Women with inadequate follow-up.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Department of Gynecology and Obsetrics

Ancona, 60123, Italy

Location

Related Publications (11)

• Baalbergen A, Smedts F, Ewing P, Snijders PJ, Meijer CJ, Helmerhorst TJ. HPV-type has no impact on survival of patients with adenocarcinoma of the uterine cervix. Gynecol Oncol. 2013 Mar;128(3):530-4. doi: 10.1016/j.ygyno.2012.12.013. Epub 2012 Dec 19.

  PMID: 23262207 RESULT

• Liverani CA, Di Giuseppe J, Giannella L, Delli Carpini G, Ciavattini A. Cervical Cancer Screening Guidelines in the Postvaccination Era: Review of the Literature. J Oncol. 2020 Nov 5;2020:8887672. doi: 10.1155/2020/8887672. eCollection 2020.

  PMID: 33204265 RESULT

• Ciavattini A, Giannella L, De Vincenzo R, Di Giuseppe J, Papiccio M, Lukic A, Delli Carpini G, Perino A, Frega A, Sopracordevole F, Barbero M, Gultekin M. HPV Vaccination: The Position Paper of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV). Vaccines (Basel). 2020 Jul 2;8(3):354. doi: 10.3390/vaccines8030354.

  PMID: 32630772 RESULT

• Park KJ. Cervical adenocarcinoma: integration of HPV status, pattern of invasion, morphology and molecular markers into classification. Histopathology. 2020 Jan;76(1):112-127. doi: 10.1111/his.13995.

  PMID: 31846527 RESULT

• Fontham ETH, Wolf AMD, Church TR, Etzioni R, Flowers CR, Herzig A, Guerra CE, Oeffinger KC, Shih YT, Walter LC, Kim JJ, Andrews KS, DeSantis CE, Fedewa SA, Manassaram-Baptiste D, Saslow D, Wender RC, Smith RA. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. CA Cancer J Clin. 2020 Sep;70(5):321-346. doi: 10.3322/caac.21628. Epub 2020 Jul 30.

  PMID: 32729638 RESULT

• Talaat A, Brinkmann D, Dhundee J, Hana Y, Bevan J, Irvine R, Bailey S, Woolas R. Risk of significant gynaecological pathology in women with glandular neoplasia on cervical cytology. Cytopathology. 2012 Dec;23(6):371-7. doi: 10.1111/j.1365-2303.2011.00891.x. Epub 2011 Jul 12.

  PMID: 21749501 RESULT

• Koh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Clark R, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jan;17(1):64-84. doi: 10.6004/jnccn.2019.0001.

  PMID: 30659131 RESULT

• Teoh D, Musa F, Salani R, Huh W, Jimenez E. Diagnosis and Management of Adenocarcinoma in Situ: A Society of Gynecologic Oncology Evidence-Based Review and Recommendations. Obstet Gynecol. 2020 Apr;135(4):869-878. doi: 10.1097/AOG.0000000000003761.

  PMID: 32168211 RESULT

• Stolnicu S, Barsan I, Hoang L, Patel P, Terinte C, Pesci A, Aviel-Ronen S, Kiyokawa T, Alvarado-Cabrero I, Oliva E, Park KJ, Abu-Rustum NR, Pike MC, Soslow RA. Stromal invasion pattern identifies patients at lowest risk of lymph node metastasis in HPV-associated endocervical adenocarcinomas, but is irrelevant in adenocarcinomas unassociated with HPV. Gynecol Oncol. 2018 Jul;150(1):56-60. doi: 10.1016/j.ygyno.2018.04.570. Epub 2018 May 30.

  PMID: 29859673 RESULT

• Rositch AF, Soeters HM, Offutt-Powell TN, Wheeler BS, Taylor SM, Smith JS. The incidence of human papillomavirus infection following treatment for cervical neoplasia: a systematic review. Gynecol Oncol. 2014 Mar;132(3):767-79. doi: 10.1016/j.ygyno.2013.12.040. Epub 2014 Jan 7.

  PMID: 24412508 RESULT

• Perez S, Inarrea A, Perez-Tanoira R, Gil M, Lopez-Diez E, Valenzuela O, Porto M, Alberte-Lista L, Peteiro-Cancelo MA, Treinta A, Carballo R, Reboredo MC, Alvarez-Arguelles ME, Purrinos MJ. Fraction of high-grade cervical intraepithelial lesions attributable to genotypes targeted by a nonavalent HPV vaccine in Galicia, Spain. Virol J. 2017 Nov 6;14(1):214. doi: 10.1186/s12985-017-0879-1.

  PMID: 29110680 RESULT

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 4, 2022
• Study Start: June 30, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 20, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)