Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Patients with cervical cancer scheduled to be treated with the LEEP procedure.

Tissue sample removed from cervix using LEEP and contrast agent.

Loop Electrosurgical Excision Procedure (LEEP)

Michele Follen, MD, PhD

The hypothesis of this research project is that topical application of the anti-EGFR or anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial variations in expression that correlate with the presence of cervical precancer. To gather feasibility data the investigators will:

1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).
2. After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high resolution optical images before and after applying contrast agents topically to the epithelial surface of the tissue for 30 minutes before rinsing.
3. Submit the specimen for histology, and have it sectioned and stained using both H\&E and immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and of EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those obtained from the intact cervix exposed to the contrast agent.

During your scheduled colposcopy, a sample of tissue will be removed from your cervix using the loop electrosurgical excision procedure (LEEP). The LEEP is the standard of care treatment for the precancerous condition on your cervix. The details of the procedure will be covered in another consent form. Before the LEEP, a photograph will be taken of the cervix. This photograph will be taken for research purposes, so that researchers will have a photograph to compare to the images taken with the MDC and Confocal.

The tissue that is removed will be taken to a room where the researchers will use a special microscope to look at the tissue before and after the new contrast agent is painted on the surface of the tissue. After the tissue samples are looked at, they will be sent to the lab for routine tests (as part of your standard of care).

You will require a LEEP whether you participate in this study or not. The tissue removal is a standard part of the LEEP. The experimental portion of this study is the use of the contrast agent. Once that portion is complete, the tissue will be tested as per standard of care. The tissue will not be used for any other research testing.

You will not be told of any of the experimental findings with the contrast agent. However, your doctor and/or nurse practitioner will be told the results of the routine tests, and they will give these results to you.

This is an investigational study. The LEEP is considered standard of care and any charges associated with the LEEP will be the responsibility of you and/or your insurance provider. Up to 80 women will take part in this multicenter study. Up to 40 will be enrolled at M.D. Anderson.

Tissue sample removal from the cervix using LEEP during the scheduled colposcopy.

Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Infections

Immune System Diseases

Recurrence

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Nitrous Oxide

Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Cryotherapy

Michael Chung, MD

The purpose of this study is to compare the rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 3 weeks of follow-up.

The recent scale-up of antiretroviral treatment programs in resource-limited settings provides an unprecedented opportunity to implement a comprehensive cervical cancer screening and treatment program for women who, by virtue of having HIV, are at significant risk for cervical disease. Unfortunately, even if screening is offered free of charge to millions of women living with HIV, it is unclear which treatment modality for pre-cancerous cervical lesions will be most effective since HIV appears to affect outcomes of treatment by increasing the recurrence and severity of cervical disease. Cervical treatment may also increase shedding of HIV from the cervix which may put discordant couples at risk and possibly spread HIV more widely. This study proposes to randomize HIV-positive women with cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) to cryotherapy vs. loop electrosurgical excision procedure (LEEP) and measure the recurrence of cervical disease in each group over 2-years of follow-up as well as HIV shedding from the cervix for 6 weeks after treatment.

Our hypothesis is that compared to cryotherapy, LEEP is significantly more likely to prevent recurrence of cervical lesions over 2 years of follow-up and less likely to cause shedding of HIV-1 from the cervix over 3 weeks of follow-up.

Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women

Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women

Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up

Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up

University of Nairobi

International Agency for Research on Cancer

University of Washington

Associate Professor

We used Division of AIDS Table for Grading the Severity of Adult Adverse Events version 1.0.

Adverse Events were monitored/assessed without regard to the specific Adverse Event Term

Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix

Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Loop Electrosurgical Excision Procedure

Total

Not all women provided age or a date of birth at baseline

Age, Categorical

Age, Continuous

Sex: Female, Male

Kenya

Region of Enrollment

Some women were uncertain of prior screening status

Previously screened for cervical cancer

1) Conducted in a single center with one clinician administering all procedures 2) Human papillomavirus-type specific results not available 3) HIV factors vary with time 4) Longer follow-up is necessary 5) Imbalance in cervical HIV RNA at baseline

Dr. Michael H. Chung

Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women

Baseline and Week 1

Baseline and Week 2

Baseline and Week 3

Shedding of HIV-1 From the Cervix Between HIV-positive Women

Overall Study

Virus Diseases

Papilloma

Immediate Treatment - LEEP - Loop electrosurgical excision procedure

1. loop electrosurgical excision procedure

loop electrosurgical excision procedure (LEEP)

Laurie Elit, MD

Mark Levine, MD

Jim Julian, MMath

This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.

In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia	NCT00511615	Cervical Cancer	Loop Electrosur...	18 Years -	M.D. Anderson Cancer Center
Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women	NCT01298596	Cervical Intrae...	Loop Electrosur... Cryotherapy	18 Years -	University of Washington
Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women	NCT01298596	Cervical Intrae...	Loop Electrosur... Cryotherapy	18 Years -	University of Washington
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1	NCT00156026	Cervical Intrae...	loop electrosur...	16 Years -	Ontario Clinical Oncology Group (OCOG)
Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia	NCT00511615	Cervical Cancer	Loop Electrosur...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for loop electrosurgical excision procedure (leep)