Neoplasms

All Conditions

Rare Diseases

Paget Disease, Extramammary

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Extramammary Paget Disease

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Antipyretics

Analgesics

Anti-Infective Agents

Lidocaine

Imiquimod

Petrolatum

Acetaminophen

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Analgesics, Non-Narcotic

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Emollients

Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.

topical 5% imiquimod cream 3 times a week for 16 weeks.

paracetamol

lidocaine in Vaseline ointment

Joanne de Hullu, MD PhD

The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.

Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.

The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.

Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response

Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.

Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions:

1. Have you used paracetamol during treatment?

   1. How many days?
   2. What dosage?
   3. Was the use sufficient?
2. Have you used lidocaine in Vaseline ointment during treatment?

   1. How many days?
   2. What dosage?
   3. Was the use sufficient?
3. Have you stopped the treatment with imiquimod because of side effects/pain?

Most common adverse events will be evaluated with the following questions:

1. Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
2. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
3. Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.

Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of

The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.

The questionnaire DLQI (Dermatology Life Quality Index) will be used.

The questionnaire FSDS (Female Sexual Distress Scale) will be used.

Leiden University Medical Center

University Medical Center Groningen

Erasmus Medical Center

The Netherlands Cancer Institute

UMC Utrecht

Catharina Ziekenhuis Eindhoven

University Medical Center Nijmegen

MD PhD

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin Diseases

Vaginal Diseases

Vulvar Diseases

All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN.

Maureen A. Lemens, R.N.

Karen P Ishitani, RN

Jamie N. Bakkum-Gamez, M.D.

In addition to evaluating treatment outcomes, tissue samples and swabs will be collected as part of this study to allow physicians to better understand Extramammary Paget's Disease (EMPD). The researchers also want to learn more about the microorganisms (microbiome) that live on or near the areas of skin affected by EMPD, in order to better understand this condition.

This is a prospective cohort study. Patients with Extramammary Paget's Disease (EMPD), specifically women with vulvar/perianal Paget's disease, will be identified during presentation to either the Dermatology Department or Gynecologic Surgery department at Mayo Clinic.

During physical exam, the patients will undergo skin/rectum/vagina cultures to evaluate the microbiome in these patients. The patients will be entered into the established care pathway for EMPD. They will be asked to complete sexual health questionnaires including: The Women's Health Clinical Questionnaires include the Menopause Rating Scale (MRS)1, Perceived Stress Scale2, Brief Resilience Scale (BRS)3, LASA Quality of Life Assessment4, Female Sexual Function Index (FSFI)5, Female Sexual Distress Scale-Revised6, Kansas Marital Satisfaction Scale7, and Pittsburgh Sleep Quality Index (PSQI)8.

The patients will be referred to Women's Health Clinic as part of the care pathway and will undergo preoperative genital sensory testing (GST) which measures sensation of the clitoris, vulva, and vagina. The patients will have a Dermatology consultation and Moh's micrographic procedure as indicated. If choosing to proceed with surgical intervention, the patients will then undergo an excisional procedure with the Department of Gynecologic surgery. Swabs, urine and tissue will be collected prior to procedures or surgery for microbiome analysis.

Tumor tissues will be obtained in order to perform tumor molecular profiling to identify targetable somatic mutations in EMPD.

The vulvar and perianal microbiome of women with extramammary Paget's disease will be evaluated.

Gynecologic Extramammary Paget's Disease

Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease

Prospective data including patient demographic information, surgical outcomes, surgical morbidity, recurrence, and long-term survival in extramammary Paget's disease (EMPD) will be collected as part of this registry..

Mayo Clinic

Principal Investigator

Blood and Lymph Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma, Squamous Cell

Melanoma

Vulvar Neoplasms

Lymphadenopathy

Skin Neoplasms

Anus Neoplasms

Carcinoma, Merkel Cell

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Lymphatic Diseases

Penile Cancer

Anal Cancer

Vulvar Cancer

Merkel Cell Carcinoma

Urethral Cancer

Neuroendocrine Tumor

Neuroepithelioma

Patients in this arm will have the procedure done through the three port minimally invasive approach.

Patients in this arm will have the traditional, open approach in conjunction with a sartorius muscle transposition.

Minimally invasive, three port approach, (using a laparoscope to perform a procedure previously performed through open surgery).

Videoscopic procedure

Open surgical procedure, with sartorius muscle transfer.

Open, traditional approach

Keith Delman, MD

Patients with melanoma, some other rare skin cancers, and some cancers of the penis and scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called the groin. Medically, this area is called the inguinal area. At present, for melanomas and skin cancers this type of spread is usually found with a special test called a "sentinel lymph node biopsy". This procedure can find spread of even a few cells in a single lymph node-allowing the treating doctor to find the spread very early.

Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot have any evidence of cancer having spread either by physical examination or by radiology tests, the lymph nodes in this area are removed to check and see if there is cancer in them. This is called staging.

At present, the standard way to remove all of the lymph nodes in the groin is by a large incision, approximately 8-10 inches in length. For patients who have this operation, there is a very high incidence of infection after surgery: as many as 50% as patients can have a problem after surgery. These infections range from a low grade skin infection needing oral antibiotics to deep infections requiring the wound to be opened and occasionally needing readmission to the hospital and antibiotics given via the vein.

With the advent of new technology and new equipment, the ability to perform this procedure through small incisions away from the groin and further down the leg has become possible. This procedure has never been performed routinely nor compared side by side to the standard open approach. The investigators propose to perform this protocol in two phases.

The investigators have performed procedures in 20 groins to this point and have confirmed the number of lymph nodes and visually verified that the procedure is identical to the open procedure. The investigators performed these procedures in order to insure that the investigators were offering an equivalent option regardless of which procedure the patient is randomized to.

The study will involve the randomization of patients undergoing the procedure. The investigators will randomize the next 110 patients in a 2:1 fashion (two people will get the videoscopic procedure for every one who gets the open procedure) until 73 patients are included in the video arm and 37 in the open arm. Outcomes including recurrence rate, duration of drain requirements, and incidence of lymphedema will be followed. Patients will be followed using standard of care processes, including regular office visits, physical exams, and radiographic imaging, when indicated. Patients will be followed for 5 years.

Inguinal lymphadenectomy is the standard procedure used to treat patients with metastatic lymphadenopathy to the groin. For melanoma, the majority of these patients are diagnosed via sentinel lymph node biopsy, which identifies disease at a very early stage. In up to 80% of patients no additional disease is identified in the lymphadenectomy specimen1,2, which is performed at a separate setting from the initial biopsy, unlike in breast cancer. Unfortunately, due to the nature of the incision and the location, inguinal lymphadenectomy is associated with an extremely high incidence of postoperative wound complications. As many as 50% of patients will develop wound infections ranging from simple cellulitis to significant wound abscesses requiring a reopening of the incision and considerable wound care, sometimes necessitating rehospitalization.3 These data are associated with an open procedure, generally requiring a 10-15 cm incision. Recently, a videoscopic approach to this procedure has been described.4 It has been well-proven that a minimally invasive approach to cancer surgery does not have a negative impact on outcomes from cancer treatment.5 Emory has long been at the forefront of minimally invasive surgery and it is only appropriate that the investigators continue to lead the field. As one of the busiest melanoma centers in the country, the investigators have the opportunity to demonstrate the utility of this approach and continue to lead the field in both cancer therapy and minimally invasive surgery.

The trial will randomize patients to either videoscopic or open lymphadenectomy to determine if there is any difference in wound complication rate and as a secondary endpoint, time to recurrence. It is expected that there will be a substantial (approximately 25% incidence versus traditional 50% incidence or half of the number of wound complications) decrease in the incidence of wound complications after minimally invasive lymphadenectomy. This is expected predominantly for two reasons: 1. The wounds for this procedure are outside of the groin, in contrast being located on the thigh, a less difficult area for healing; and 2. The wounds are markedly shorter in length, making wound healing easier. The investigators would expect recurrence patterns to be identical in the two groups. The investigators have performed 20 procedures using the minimally invasive approach, and our experience to this point has demonstrated that the mean and median number of nodes harvested was 9 and 10.5 respectively. Median procedure duration has been 147 minutes and there have been 3 patients (15%) with complications (1 seroma, 2 with superficial cellulitis) but there have been no wound dehiscences or superficial breakdowns.

While the investigators do not have immediate access to the entire dataset of patients treated at Emory with the open approach, the investigators do have complete data on the 40 patients most recently treated (over the last 2 years). Of these 40 patients, 17 (43%) had complications other than lymphedema. Of these, 5 required hospitalization and two had complete wound dehiscences requiring management with a wound vacuum-assisted closure (VAC). This data is not complete, but reasonably reflects the Emory experience and allows us to conclude that our data is similar to that reported in the literature historically.

While many minimally invasive approaches to open procedures have been applied without randomized trials proving their efficacy (splenectomy, hepatectomy, pancreatectomy, partial gastrectomy, to name a few), the investigators believe it is prudent when adopting a new approach for a cancer operation to study it in a prospective fashion. This is the only trial of its kind and the investigators are one of only a few centers in the world that has the minimally invasive knowledge and expertise and the volume of urologic and melanoma patients to have the potential to perform such a trial. It is incumbent upon us to complete this study.

The goal of this study is to determine if a videoscopic approach to a standard procedure offers a better outcome for patients with respect to wound complications and to prove that there is no inferiority between the videoscopic approach and the traditional open approach from a cancer outcome standpoint, specifically time to recurrence and nodal yield.

Patients will be considered for this study if they are between age 18 and 80, have either metastatic melanoma or merkel cell carcinoma diagnosed by sentinel lymph node biopsy or have indications for inguinal lymphadenectomy for urological malignancy.

The study will be designed as a randomized, prospective trial, analyzing wound complications as the primary endpoint and recurrence-free survival as a secondary endpoint. Our sample size calculation (see section 8.0 below) indicate that a sample size of 73 patients in the study arm and 37 patients in the control arm will be sufficient to detect a moderate-to-strong effect with an 80% power and a 95% level of statistical significance.

Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

Videoscopic Versus Open Inguinal Lymphadenectomy for Sentinel Node Positive Cutaneous Malignancies and Genitourinary Staging Procedures

The primary objective is to assess wound infection, wound dehiscence and other wound complications.

Assessment of lymphedema will be determined in all patients to identify if there is a difference in all patients undergoing either videoscopic or open inguinal lymphadenectomy.

This will characterize, as a surrogate of completeness of surgery, the number of nodes retrieved at the surgical procedure via either approach.

To assess differences in readmission rates between the two groups.

Recurrence free and overall survival will be measured in patients undergoing the procedure to determine if the procedure impacts survival at all.

Emory University

Associate Professor of Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Topical 5% Imiquimod Cream for Vulvar Paget's Disease	NCT02385188	Paget Disease, ...	Imiquimod paracetamol lidocaine in Va...	18 Years -	University Medical Center Nijmegen
Gynecologic Extramammary Paget's Disease	NCT03564483	Extramammary Pa... Extramammary Pa... Paget Disease, ... Extramammary Pa... Extramammary Pa... Extramammary Pa... Extramammary Pa... Extramammary Pa... Extramammary Pa...		18 Years -	Mayo Clinic
Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer	NCT01526486	Melanoma Merkel Cell Car... Squamous Cell C... Penile Carcinom... Urethral Carcin... Extramammary Pa... Scrotal Carcino... Anal Cancer Vulvar Cancer Skin Cancer Lymphadenopathy	Videoscopic pro... Open, tradition...	18 Years - 80 Years	Emory University
Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer	NCT01526486	Melanoma Merkel Cell Car... Squamous Cell C... Penile Carcinom... Urethral Carcin... Extramammary Pa... Scrotal Carcino... Anal Cancer Vulvar Cancer Skin Cancer Lymphadenopathy	Videoscopic pro... Open, tradition...	18 Years - 80 Years	Emory University

Spots Global Cancer Trial Database for extramammary paget's disease