Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Tumor RNA transfected dendritic cells

The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease.

The specific aims are: 1) to evaluate, in a phase I clinical trial, the safety of vaccinating patients with dendritic cells transfected with RNA from autologous cancer cells; 2) to analyze the T cell responses induced by the treatment; and 3) to improve the efficacy of the treatment by developing methods to increase the induction of CD4+T cell responses.

Tumor RNA Transfected Dendritic Cell Vaccines

US Department of Veterans Affairs

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients randomized into this group will follow normal standard of care in Nova Scotia

Patients randomized into this group will be part of the active arm of the study. They will be pre-screened and asked the following questions:

1. Sign an Information and Authorization form
2. Demographic data: gender, date of birth, ethnicity
3. Health history (duration of lesion, changes in lesion, specific changes, who identified the lesion, measurement in two greatest dimensions radially and color.

Pre-screening for melanoma by qualified nurse

active

Richard G Lngley, PhD

The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse using a dermatoscope, triaging suspicious lesions vs. benign lesions. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

Melanoma Accuracy Study; Phase 2

Melanoma Accuracy Study, Phase Two

Pre-screening referrals to the Department of Dermatology by a qualified nurse for patients with lesions, low to moderate risk for melanoma, would facilitate a more timely diagnosis of melanoma, and appropriate triaging of benign lesions.

Nova Scotia Health Authority

Eligible participants will undergo an unknown number of Avatar-life review sessions depending on acceptability of the intervention to subjects and the capacity of the team to provide the intervention.

VoicingHan will screen-capture patient's storytelling performances as video files. Immediately before the first intervention, patients will complete an array of self-reported questionnaires to assess physical, spiritual, and psychological well-being and elicit relevant demographic and medical information. The assessments include the ESAS, FACIT-Sp subscale, and EORTC PAL 15. Subsequent administration of these questionnaires spaced 2-4 weeks apart will occur before each avatar session (pre-intervention). This will determine if intensity of the patient's symptoms have changed over the course of the intervention. Following completion of the Avatar session, a member of the research team will conduct a semi-structured, open-ended interview to assess patients' perception of intervention components and identify possible factors influencing intervention feasibility and any technical barriers.

Avatar Life Review

Egidio Del Fabbro, MD

The objective of the study is to determine the feasibility and acceptability of an integrated art and technology, storytelling, life review platform for patients with active cancer. The VoicingHan project is an avatar storytelling platform designed for patients with advanced cancer receiving palliative care at Virginia Commonwealth University's Massey Cancer Center. VoicingHan supports terminally ill patients by using oral storytelling as an artistic medium to facilitate patients' interactive performances. Movement-based, creative expression has been shown to reduce stress and depression. By projecting movement-based actions onto an avatar, this can serve as a tool to express emotional distress, address satisfaction with care, and view cancer in a different light.

Life reviews have been used in palliative care to help individuals integrate memories into a meaningful whole, providing a balanced view of the past, present and future. Life review is also an evaluative process, enabling participants to examine how memories contribute to the meaning of their life.

VoicingHan, the software program that will be used in this study, provides an illusion that the Avatar is speaking, allowing users to observe their stories in real time, potentially encouraging deeper reflection and memory retrieval. The technology uses motion capture (MoCap) to translate human movement into a digital platform. MoCap offers several advantages: lightweight, sensitive to minute movement, and user-friendly.

Patients will select avatars from different age groups during their sessions, allowing them to retrieve specific, positive memories of different lifetime periods and facilitating a more candid autobiographical memory. Creative expression may serve as a vehicle for patients with a life limiting illness in finding purpose and creating a sense of meaning. The integration of art and technology into a storytelling, life-review platform through means of engaging the physical, psychological, and spiritual domains will support patients to contemplate their own mortality.

This study will use a one-group observational design to establish feasibility and acceptability of Avatar therapy intervention in patients with advanced cancer.

Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer

The total number of sessions completed in compliance with the required protocol divided by the total number of sessions attempted

The research coordinator will conduct an open-ended interview to assess patients' perception of intervention components and identify possible factors influencing feasibility. Questions will address feasibility of setup time, study procedure, and level of comfort

Feasibility of recruitment efforts will be determined by the proportion of patients that are enrolled divided by the number of patients contacted and approached to participate.

length of setup time as determined when first entering the outpatient room to the arrival of the patient

Length of session as determined by the start of participant's arrival to their departure.

Participants will complete a 3 item brief survey administered by the research coordinator at the end of each session to determine if patients would benefit from another avatar session. Each item is rated on a five-point Likert scale from "1= Not at all to "5= A lot/Extremely" with higher scores indicating greater patient satisfaction.

Massey Cancer Center

Virginia Commonwealth University

Infections

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Pharmaceutical Solutions

Anti-Infective Agents

Central Nervous System Depressants

Hydrogen Peroxide

Ethanol

Anti-Infective Agents, Local

A-101 45% (Topical solution, hydrogen peroxide 45%)

Topical solution, isopropyl alcohol and water

A-101 45% (hydrogen peroxide 45% topical solution)

Active

Vehicle solution containing isopropyl alcohol and water

Vehicle

Judy Schynder

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study

The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.

A Study of A-101 Topical Solution for the Treatment of Common Warts

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137.

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60.

Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137.

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Aclaris Therapeutics, Inc.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.

Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.

Topical solution, hydrogen peroxide 45%

A-101: hydrogen peroxide 45% topical solution

Topical solution, isopropyl alcohol and water

Vehicle: Vehicle solution containing isopropyl alcohol and water

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fitzpatrick Skin Type

Prior Treatment of any Wart Treated

Total Warts Treated

Time Since First Appearance of Most Recent Wart Treated

Time since First Appearance of Least Recent Wart Treated

Thickness of "Largest" Wart Treated

Longest Axis of "Largest" Wart Treated

Aclaris Clinical Operations

A summary of the wart clearance at Visit 10.

Warts at Baseline - All

Warts at Baseline - 1

Warts at Baseline - 2

Warts at Baseline - 3

Warts at Baseline - >3

The study's primary endpoint was to evaluate the amount of patients achieving a clearance of all baseline WARTS. Patients were stratified by the amount of WARTS at Baseline.

The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)

P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.

Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)

Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)

A median was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tumor RNA Transfected Dendritic Cell Vaccines	NCT00108264	Prostate Cancer	Tumor RNA trans...	10 Years -	VA Office of Research and Development
Melanoma Accuracy Study; Phase 2	NCT03464604	Melanoma	active	18 Years -	Nova Scotia Health Authority
Melanoma Accuracy Study; Phase 2	NCT03464604	Melanoma	active	18 Years -	Nova Scotia Health Authority
Melanoma Accuracy Study; Phase 2	NCT03464604	Melanoma	active	18 Years -	Nova Scotia Health Authority
Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer	NCT03996642	Cancer	Avatar Life Rev...	18 Years -	Virginia Commonwealth University
A Study of A-101 Topical Solution for the Treatment of Common Warts	NCT03691831	Common Wart	Active Vehicle	2 Years -	Aclaris Therapeutics, Inc.

Spots Global Cancer Trial Database for active

Every month we try and update this database with for active cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for active

Every month we try and update this database with for active cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for active cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.