Adenocarcinoma of the Uterine Cervix and HPV
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05267834 |
|
Recruitment Status :
Not yet recruiting
First Posted : March 4, 2022
Last Update Posted : May 27, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Adenocarcinoma of the Uterine Cervix | Procedure: Conization and/or Hysterectomy |
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.
| 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 |
| 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 |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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.
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
| Contact: Luca Giannella | +393495787181 | lucazeta1976@libero.it |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Cervical Adenocarcinoma HPV Type Screening Program Treatment |
Recurrence Survival Follow-up |
|
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |