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Adenocarcinoma of the Uterine Cervix and HPV

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ClinicalTrials.gov Identifier: NCT05267834
Recruitment Status : Not yet recruiting
First Posted : March 4, 2022
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Luca Giannella, Università Politecnica delle Marche

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.

Condition or disease Intervention/treatment
Adenocarcinoma of the Uterine Cervix Procedure: Conization and/or Hysterectomy

Detailed Description:

The incidence of cervical cancer in developed countries declined considerably in the last few decades. This has been possible for efficient screening programs to which HPV vaccines have been added over the past 15 years. Despite this global reduction in cervical lesions, the incidence of adenocarcinoma of the uterine cervix (AC) increases in invasive and in situ stages. This increase mainly affects women aged 30-40, with an incidence of 11.2 per 100.000 women. On the contrary, the squamous histological lesions revealed an increase in the incidence of in situ lesions and a concomitant reduction of invasive stages. These data would seem to suggest a delay in the diagnosis of cervical glandular lesions, a shorter interval of disease progression from the adenocarcinoma in situ (AIS) to infiltrating stages, or a different process of carcinogenesis.

Most glandular cervical lesions occur at an early stage. The standard of treatment for in situ or micro-invasive lesions is extra fascial hysterectomy (AIS or stage 1A1 with no LVSI) or modified radical hysterectomy with pelvic lymph node dissection (stage 1A1 with LVSI, or 1A2). In fertility-sparing treatment, conization or radical trachelectomy with pelvic lymph node dissection is an option.

Another aspect that differentiates cervical adenocarcinoma from squamous lesions is the link with HPV infection. In 2018, the International Endocervical Criteria and Classification categorized cervical glandular lesions into HPV-associated and non-HPV-associated AC. Unlike cervical squamous lesions, which are almost all linked to high-risk HPV types, AC can be HPV negative in up to 15-20% of cases. The HPV 18 genotype is the most represented in AC with a rate of 38-50% in AIS and 50% in invasive stages. Based on some studies, it appears that non-HPV-related lesions have worse outcomes. This can significantly impact screening programs where 14 high-risk HPVs are tested.

In a recent study including 341 surgical specimens of AC, 100% of non-HPV-related lesions were classified as Silva Pattern C (the worst prognostic pattern). Instead, no impact of the HPV genotype was found on 113 women with AC during a follow-up of 5 years. HPV 45 showed a shorter 5-year survival than HPV 16 or 18.

While for advanced lesions, the stage itself represents the most important prognostic factor of recurrence or survival, in situ or micro-invasive lesions may represent the best target for evaluating other prognostic factors.

Give the pivotal role of HPV testing in screening programs, availability of large multicenter studies on HPV-type related AC will provide more robust evidence regarding screening policies and hence, improve prevention, treatment and follow-up outcome and prognosis of an increasing cervical pathology.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: In Situ/Microinvasive Adenocarcinoma of the Uterine Cervix and HPV-type Impact: Pathologic Features, Treatment Options, and Follow-up Outcomes - Cervical Adenocarcinoma Study Group (CAS-Group).
Estimated Study Start Date : June 30, 2022
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Group/Cohort Intervention/treatment
Positive high-risk HPV
Women with adenocarcinoma of the uterine cervix and positive for high-risk HPV (genotype16/18/31/33/35/39/45/51/52/56/58/59/66/68).
Procedure: Conization and/or Hysterectomy
Women undergoing loop electrosurgical excision procedure or simple/modified/radical hysterectomy

Negative high-risk HPV
Women with adenocarcinoma of the uterine cervix and negative for high-risk HPV (genotype16/18/31/33/35/39/45/51/52/56/58/59/66/68).
Procedure: Conization and/or Hysterectomy
Women undergoing loop electrosurgical excision procedure or simple/modified/radical hysterectomy




Primary Outcome Measures :
  1. Overall recurrence at 1 year in HPV positive vs HPV negative women [ Time Frame: At 1 years ]
    Number of women who have recurrence after treatment divided by total number of patients at onset

  2. Overall recurrence at 3 years in HPV positive vs HPV negative women [ Time Frame: At 3 years ]
    Number of women who have recurrence after treatment divided by total number of patients at onset

  3. Overall recurrence at 5 year in HPV positive vs HPV negative women [ Time Frame: At 5 years ]
    Number of women who have recurrence after treatment divided by total number of patients at onset

  4. Overall survival at 5 year in HPV positive vs HPV negative women [ Time Frame: At 5 years ]
    Number of women who are alive after treatment divided by total number of patients at onset

  5. Rate of histological outcomes (Usual type, Villoglandular, Mucinous-NOS, Mucinous-intestinal, Invasive stratified mucin-producing, Micropapillary, 'Serous'-like, Gastric type, Clear cell, Mesonephric, Endometrioid) in HPV positive vs HPV negative women [ Time Frame: at enrollment ]
    Number of women with specific histological findings in HPV positive vs HPV negative patients

  6. Rate of colposcopic features (negative colposcopy, minor colposcopic changes, major colposcopic changes) in HPV positive vs HPV negative women [ Time Frame: at enrollment ]
    Number of women with specific colposcopic findings in HPV positive vs HPV negative patients

  7. Treatment modality rate (conization, hysterectomy) in HPV positive vs HPV negative women [ Time Frame: at enrollment ]
    Number of women undergoing conization or hysterectomy in HPV positive vs HPV negative patients


Secondary Outcome Measures :
  1. Overall recurrence at 1 year in HPV-16/18 vs non-HPV-16/18 positive women [ Time Frame: At 1 years ]
    Number of women who have recurrence after treatment divided by total number of patients at onset

  2. Overall recurrence at 3 years in HPV-16/18 vs non-HPV-16/18 positive women [ Time Frame: At 3 years ]
    Number of women who have recurrence after treatment divided by total number of patients at onset

  3. Overall recurrence at 5 year in HPV-16/18 vs non-HPV-16/18 positive women [ Time Frame: At 5 years ]
    Number of women who have recurrence after treatment divided by total number of patients at onset

  4. Overall survival at 5 year in HPV-16/18 vs non-HPV-16/18 positive women [ Time Frame: At 5 years ]
    Number of women who are alive after treatment divided by total number of patients at onset



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267834


Contacts
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Contact: Luca Giannella +393495787181 lucazeta1976@libero.it

Sponsors and Collaborators
Università Politecnica delle Marche
Publications of Results:

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Responsible Party: Luca Giannella, Principal Investigator, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT05267834    
Other Study ID Numbers: AC-HPV2
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luca Giannella, Università Politecnica delle Marche:
Cervical Adenocarcinoma
HPV Type
Screening Program
Treatment
Recurrence
Survival
Follow-up
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms