Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Neoplasms, Basal Cell

- CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels.

- CSC: Proliferation of keratinocytes presenting cellular atypia, crossing the JDE (invasive CSC versus in situ), glomerular vessels

Melanoma: Destructured dermal-epidermal junction (DEJ), presence of pagetoid cells, clusters of atypical melanocytes, dendritic cells

An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function

Confocal optical coherence tomography - OCTAVE

Jean francois OUDET

Marie-Hélène Barba

Pierre-André BECHEREL, Dr

Marie Barba

pierre-andre becherel, Dr

DRE RAMSAYGDS

This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

There are mainly 3 types of skin cancer: melanoma, basal cell carcinoma and squamous cell carcinoma. The diagnosis of skin cancers is now based on anatomo-pathological evidence. However, given the progress made, imaging is a technique that now has a full role in the diagnosis of these pathologies. This is particularly the case of confocal optical coherence tomography (LC-OCT), which is a recent imaging technique that has proven itself in ophthalmology with the obtaining of precise images of the retina.

LC-OCT can be applied in dermatology according to the following principle: the low intensity laser beam delivered by the LC-OCT device interferes with the melanin, is reflected and makes it possible to instantly acquire a 3D cross-sectional image of the skin, with a resolution of the order of a micrometer. It is finally an "optical echography", the light allowing a tissue definition much higher than the ultrasonic waves. It is therefore possible to obtain sections of histological resolution, and to scan the entire area studied.

Based on this principle, DAMAE has created OCTAV®, a class 1 medical device intended to allow "an in-depth study of skin pathologies", which is currently being evaluated in vivo as part of a clinical trial ( OCTAV - NCT03731247).

The device evaluated in the OCTAV trial does not include the "dermoscope" function. However, coupled with an image capture and processing system, it would increase the magnification obtained from 10 times to 20 or 30 times, allowing precise targeting of the lesion. As a result, a new prototype of OCTAV® has been developed which integrates the "dermoscope" function.

In this context, this project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)

Correlation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.

European Clinical Trial Experts Network

Ramsay Générale de Santé

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Digestive System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Keratoacanthoma

Muir-Torre Syndrome

Neoplasms, Squamous Cell

Syndrome

Lynch Syndrome II

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Sebaceous Gland Diseases

Skin Diseases, Genetic

Antineoplastic Agents

All Drugs and Chemicals

Talimogene laherparepvec

Antineoplastic Agents, Immunological

The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors.

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient.

Injection of TVEC into target lesions - week 1-2

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL withapproximately 1.15 mL in a 2 mL vial for the second and subsequent doses.

Injection of TVEC into target lesions 3wks after 1st injection

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Injection of TVEC into target lesions 2wks after 2nd injection

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.

Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Injection of TVEC into target lesions 2wks after 3rd injection

Clara Curiel, MD

This is single arm a Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).

The purpose of this study is to find out more about talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®) in people with a healthy immune system with confirmed low-risk squamous cell carcinoma. Usually, low-risk SCC is treated with a surgical procedure, but surgery can be challenging when patients have: multiple SCCs on their body, when the SCC is on a challenging place on the body to remove or when patients are older or have diseases that place them at risk for surgery related complications. Immune therapy is a treatment that uses certain parts of a person's immune system to fight disease. Immune therapy is a proven therapeutic approach in many cancers, including melanoma, another type of skin cancer.

Talimogene laherparepvec (TVEC) is made from a modified herpes simplex virus type 1 (HSV-1, the "cold sore" virus). The virus' genes were modified in a laboratory so that it produces a protein called human granulocyte macrophage colony-stimulating factor (GM-CSF), which multiplies and grows in tumor cells. Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat patients with white blood cell counts that are too low. This modified HSV-1 produces a protein that acts on tumor cells and stimulates the immune system. TVEC is administered by injection with a needle directly into one or more tumors and works by directly destroying cancer cells and enhancing immune response to destroy cancer cells.

Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer

The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).

1. Number of participants with events requiring the discontinuation of study drug

1. 75% or greater number of Target injection lesions (TILs) meeting criteria for withdrawal.
2. Identification of high-risk features in one or more TILs during study participation.
3. Persistent discomfort (consecutive weeks of lesion pain, burning, or itching of Grade 2 or more).

To measure time of response in cSCC TILs.

To measure the duration of overall response (DOR) of TILs.

Assess durable response rate (DRR) of TILs.

To measure the time to progression (TTP) of TILs

Overall response rate (ORR) (CR+PR) assessed by imaging technique (high frequency ultrasound).

Overall clinical response rate (CR+PR) of individual TILs with talimogene laherparepvec (not as overall subject response).

Overall clinical response rate (CR+PR) in cSCC Target non-injected lesion(s) (TNILs).

1. Number of safety adverse events (SAE) as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

a. Clinically significant laboratory values i. Clinically significant laboratory values are based on participant condition and side effect. These will vary and will be determined by the clinical judgement of the research healthcare provider. Note: laboratory values will be collected for initial participant screening and side effects only, no other clinical laboratory values are scheduled in this protocol.

Local effects on the tumor as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

1. Pain
2. Inflammation
3. Ulceration

Amgen

University of Arizona

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Head and Neck Neoplasms

Sarcoma

Lymphoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urologic Neoplasms

Gastrointestinal Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Soft Tissue Sarcoma

Lymphosarcoma

Patients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs.

Lay Navigation

Steve Asch, MD

The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the quality of care and care coordination across the continuum of care. The newest innovation is to introduce lay navigators to specified high-need patients. The larger goal of the project is to assess whether lay navigators can address non-clinical patient needs in a timely fashion and appropriately connect them with their clinical team when warranted. It is expected that proactive interaction with patients will decrease patient anxiety/stress related to their cancer and facilitate higher patient engagement and improved management of physical, social,and emotional health. For the pilot project, the smaller goal is to understand: how lay navigator time is used; the types and frequency of issues brought up by patients; resources that patients are given or referred to; type and frequency of mode of contact with patients; and patients' acceptance of navigators based on refusal. An electronic intake form will be used to collect this information so that data can be analyzed regularly to inform changes to the navigator program as needed.

The Stanford Cancer Institute is undergoing a 5-year Transformation Initiative that began in 2013. One of the goals of this initiative is to increase patient engagement. The underlying premise is that engaged patients will be more likely to attend all their visits, receive all their treatments, and understand ways to manage treatment side effects so that they are less likely to go to the emergency room (ER) or be admitted to the hospital. An approach being tested is to use lay navigators to help identify patient issues and help them address the issues through a combination of direct supportive activities (e.g., calling clinical team for the patient) and activities that help the patients help themselves (helping them understand when side effects warrant a call to their clinical team that they make themselves).

Information including patient acceptance/refusal of navigator services; number and types of contacts with patients (phone, in-person, email); types of issues discussed (financial, social, educational, physical, emotional, etc); referrals made; and time spent with patients for each encounter will be routinely entered by the navigators for each patient contact. The data entered will be evaluated regularly to closely monitor navigator activities and better understand cancer patient issues/needs. This information will be used to inform possible training needs of navigators, educational needs of patients,needs for better referral support,help predict navigator case-load, and other issues.

Eligibility Criteria:

All new biopsy positive cancer patients that have a treatment plan to receive at least 2 treatment modalities: surgery, chemotherapy and/or radiation therapy at Stanford are eligible. Because there will be more patients eligible than the navigators can manage, only patients with an even MRN will receive a navigator for the pilot. The overall purpose of the pilot is to learn which patients benefit most and which services navigators are able to best help with. The investigators expect the pilot to last 6-12 months. Mixed methods will be used to evaluate the navigators and will include existing patient experience surveys, unscheduled hospitalizations, ER visits, interviews with patients, staff (including navigators), and physicians regarding their experience with and perceived value of navigators.

There will be 12 groups in each arm which reflects the 12 different cancer types.

Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study

Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients

Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients.

Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients.

Comparison of the proportion of navigated patients that used non-treatment-related cancer services to those not navigated. Examples of services include palliative care, supportive care, nutrition, etc.

Stanford University

Clinical Associate Professor

Nervous System Diseases

Pain

Acute Pain

Neurologic Manifestations

Acute Graft Versus Host Disease

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Lidocaine

Anesthetics

Prilocaine

Ethyl Chloride

Lidocaine, Prilocaine Drug Combination

Anesthetics, Local

EMLA cream 5% 25g lidocaine, 25g prilocaine; Astra Zeneca. Topically applied followed by Tegaderm dressing to cover. Length of duration monitored and recorded as part of study

Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study

Ethyl chloride spray (Cryogesic®, Fannin Ltd, Dublin, Ireland). Applied topically to surgical site prior to LA injection. Spray at distance of 5-10cm for 4-8 seconds until skin slightly blanched and the fluid allowed to evaporate.

EMLA

Ethyl chloride

Aqueous cream BP

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

Operations on cutaneous tissues of the head and neck are some of the most frequently performed types of operation performed. They can often successfully be performed using local anaesthetic (LA). However, tissues in this anatomic area are some of most sensitive tissues in the body to nociceptive pain. As such, local anaesthetic can be a distressing experience for patients in many ways. Unfortunately, it is also the most common anatomical site for cutaneous malignancies. The majority of these lesions are resected under local anaesthetic. However, one of the major disadvantages of local anaesthetic such as lidocaine is pain during administration.

Several interventions have been used to reduce pain from needles and injections including ethylene chloride cryoanalgesic spray and topical anaesthetic agents including EMLA (lidocaine and prilocaine) and Ametop ointments. These have been extensively used in paediatric populations with great success to reduce pain during procedures requiring hypodermics such as cannulation. Several studies have trialled these interventions in adult populations across a variety of anatomical locations with variable results. The investigators aim to assess the efficacy of EMLA and ethyl chloride in mitigating nociceptive pain associated with local anaesthetic administration in patients undergoing cutaneous head and neck surgery.

Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.

Topical Anaesthesia in Cutaneous Head and Neck Surgery

Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial

The primary outcome measure is patient reported pain on a numeric rating scale (NRS)(1; no pain, 10; worst pain imaginable) recorded after LA administration

Patient satisfaction measured on NRS scale of 1=not bad at all, to 10=worst experience imaginable recorded immediately postoperatively

University Hospital Waterford

Principal Investigator

JCXH-211 will be delivered by intratumoral injection in 2 stages:

（Part1）Intratumoral injection stage of skin/subcutaneous lesions. According to Part 1 study results,1-2 dose groups were selected for deep lesion injection study, dose escalation will follow the "3 + 3" principle.

JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase Ia.

JCXH-211 Injection

Qi Wang

Xu R hua, professor

ruan dan yun, physician

Xu ruihua, President

: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase

1a and Phase 1b. Phase 1a has 2 stages, skin/subcutaneous lesions stage, deep (visceral) lesions stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With Malignant Solid Tumors

Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.

Safety and tolerability as determined by the incidence of adverse events （AEs）, including severe AEs and serious AEs （SAEs）.

Objective response rate is defined as the proportion of patients that achieve a complete response （CR） or partial response （PR） during the study participation.

Duration of response is defined as the time from the first assessment of tumor as CR or PR to the first assessment as progressive disease or death from any cause.

Disease control rate is defined as the proportion of patients with CR or PR or stable disease （SD） with the DoR ≥ 12weeks observed from Day 1 to disease progression.

Time to response is defined as the time from Day 1 until the first documentation of objective response （CR or PR）.

Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier.

Overall survival is defined as the time from Day 1 until death due to any cause.

Immorna Biotherapeutics, Inc.

JCXH-211 will be delivered by intratumoral injection in 3 stages:

Single administration stage A single administration of JCXH-211 administered to cutaneous or subcutaneous lesions in escalating doses.

Multiple administration stage Up to 3 doses of JCXH-211 administered to a cutaneous or subcutaneous lesion in escalating doses. Assigned dose to be determined on the data from the single administration arm.

Visceral administration stage JCXH-211 administered to a visceral lesion in escalating doses. Assigned dose to be determined on the data from the single and multiple administration arms.

JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a.

JCXH-211

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase 1a and Phase 1b. Phase 1a has 3 stages, Single administration stage, Multiple administration stage and Visceral stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.

Dose limiting toxicity, evaluated in the single administration stage of Phase 1a, which will be used to determine the MTD and to determine dose escalation

Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)

Objective response rate is defined as the proportion of patients that achieve a complete response (CR) or partial response (PR) during the study participation.

Time to response is defined as the time from Day 1 until the first documentation of objective response (CR or PR).

Disease control rate is defined as the proportion of patients with CR or PR or stable disease (SD) with the DOR ≥ 12 weeks observed from Day 1 to disease progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)	NCT05340543	Cutaneous Tumor Optical Coheren... Basal Cell Carc... Squamous Cell C... Melanoma	Confocal optica...	18 Years -	Ramsay Générale de Santé
Study of TVEC in Patients With Cutaneous Squamous Cell Cancer	NCT03714828	Squamous Cell C... Skin Cancer Keratoacanthoma Cutaneous Tumor Skin Cancer, Sq... Lesion Skin	Injection of TV... Injection of TV... Injection of TV... Injection of TV...	18 Years -	University of Arizona
Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study	NCT03245788	Breast Cancer Gynecologic Can... Neck Cancer Head and Neck C... Gastrointestina... Thoracic Cancer Cutaneous Tumor Urologic Cancer Neurologic Canc... Lymphoma Sarcoma Bone Marrow Tra...	Lay Navigation	18 Years -	Stanford University
Topical Anaesthesia in Cutaneous Head and Neck Surgery	NCT06274905	Pain, Acute Head and Neck C... Cutaneous Tumor	EMLA Ethyl chloride Aqueous cream B...	18 Years -	University Hospital Waterford
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors	NCT05727839	Cutaneous Tumor Malignant Solid...	JCXH-211 Inject...	18 Years - 75 Years	Immorna Biotherapeutics, Inc.
Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)	NCT05340543	Cutaneous Tumor Optical Coheren... Basal Cell Carc... Squamous Cell C... Melanoma	Confocal optica...	18 Years -	Ramsay Générale de Santé
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors	NCT05727839	Cutaneous Tumor Malignant Solid...	JCXH-211 Inject...	18 Years - 75 Years	Immorna Biotherapeutics, Inc.
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors	NCT05539157	Cutaneous Tumor Malignant Solid...	JCXH-211	18 Years - 75 Years	Immorna Biotherapeutics, Inc.
Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)	NCT05340543	Cutaneous Tumor Optical Coheren... Basal Cell Carc... Squamous Cell C... Melanoma	Confocal optica...	18 Years -	Ramsay Générale de Santé

Spots Global Cancer Trial Database for cutaneous tumor