Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Skin Neoplasms

Carcinoma in Situ

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Fluorouracil

Calcipotriene

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.

Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.

Apply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.

Combination cream of 5-fluorouracil and calcipotriene

Apply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days.

5-fluorouracil cream

Frederick Gibson, MD

Alexandria Riopelle, MD

Bilal Fawaz, MD

The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers.

The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with

The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.

5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer

Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ

Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). The number of participants with scores of 2 or higher will be divided by all participants.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). Mean pain ratings will be calculated with higher mean scores suggesting more severe pain.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. The number of participants with scores of 2 or higher will be divided by all participants.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. Mean redness ratings will be calculated with higher mean scores suggesting more severe redness.

For participants who experienced any redness, the mean day after treatment when the redness was worst will be calculated.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any scaling/flaking. The number of participants who responded 'yes' will be divided by all participants.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin itching. The number of participants who responded 'yes' will be divided by all participants.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin burning. The number of participants who responded 'yes' will be divided by all participants.

Compliance with treatment will be assessed by weighing the medicine tubes after treatment completion and comparing the weight, estimated in grams from fingertip units (FTU), with the expected weight based on the how much medicine should have been used given the treatment regimen. The closer this difference is to zero, the greater the compliance.

Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their satisfaction with the treatment from 1 to 5 where 1=very dissatisfied, 2= dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Mean satisfaction ratings will be calculated with higher mean scores suggesting more treatment satisfaction.

The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.

Boston University

PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes

PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses

Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Treatment

S. I. Brian Jiang, MD

This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma.

Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.

Pilot Study of PDL to Treat BCC and SCCIS

A Pilot Study to Examine the Effectiveness of 595nM Pulsed Dye Lasers in the Treatment of Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ

Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).

University of California, San Diego

Clinical Professor of Dermatology

Control

PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes

PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Setting 1

PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses

PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.

PDL Setting 2

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

S. Brian Jiang

Tumor Clearance

Overall Study

Symptoms and General Pathology

Facies

Disease Attributes

Pharmaceutical Solutions

Aminolevulinic Acid

Photosensitizing Agents

20 participants will be enrolled to this arm

Participants will have their facial isSCC prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by blue light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.

Aminolevulinic Acid 20% Topical Solution with Blue Light

Clinical Coordinator

Clinical Research Coordinator

Mark S. Nestor, MD, PhD

Mark S Nestor, M.D., Ph.D.

Mark S Nestor, MD, PhD

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive cream used in combination with a light source.

The main questions this trial aims to answer are:

* to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and;
* seeing how many participants had no remaining affected facial skin cancer sections after treatment.

Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

In the study, participants will be asked to complete the following:

* Provide basic personal information (including date of birth, gender, race and ethnicity)
* Provide their medical/ surgical history and perform a medical exam (including but not limited to physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
* Follow study rules such as avoiding certain medications and treatments
* Allow photographs of the area of skin cancer being treated on the face
* Provide information on any medications, treatments or reactions that started after the study began
* Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source
* Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
* Allow surgery to remove the skin cancer area from the face for Laboratory testing

To qualify for this trial, participants must:

* be an adult (18 years of age or older)
* give voluntary written consent
* have a recently diagnosed (less than six months from first visit) skin cancer area on the face that meets surgery size requirements
* be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
* (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
* confirm they are not sensitive to any of the study treatment ingredients

All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing. All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) + Blue Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports

Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site.

Observations and changes noted in the aesthetic appearance (Erythema, Flaking/ Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of the treated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presence and 4 as a severe outcome.

Sun Pharmaceutical Industries Limited

The Center for Clinical and Cosmetic Research

Director

STP705 30 μg dose, intralesional injection, given once a week for 6 weeks.

STP705 60 μg dose, intralesional injection, given once a week for 6 weeks.

STP705 90 μg dose, intralesional injection, given once a week for 6 weeks.

Placebo (normal saline), intralesional injection, given once a week for 6 weeks.

STP705 selected dose 1, intralesional injection, given once a week for 6 weeks.

STP705 selected dose 2, intralesional injection, given once a week for 6 weeks.

The STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively.

STP705

Placebo Saline

Mark Nestor, MD

David Goldberg

Michael Gold, MD

Edward Lain, MD

Kenneth Beer, MD

Brenda LaTowsky, MD

Edward Primka, MD

Girish Munavalli, MD

Brian Jiang, MD

Megan Couvillion, MD

Mark Ling, MD

The purpose of this trial is to evaluate safety, tolerability and efficacy of various doses of STP705 administered as intralesional injection in subjects with cutaneous squamous cell carcinoma (in situ) skin cancer (isSCC).

This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with isSCC.

A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once weekly for 6 weeks.

After 6 weeks, the lesion will be excised.

In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705 doses or placebo.

An interim analysis will be done after all subjects have completed end of treatment (EOT) visits to determine 2 selected dose levels of STP705 to be used in part of the study.

In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses (from part 1) or placebo.

In both parts at the End of Treatment (EOT), the lesion will be excised.

Part 1: 40 subjects randomized in a 1:1:1:1 ratio to receive 6 weeks of treatment of placebo, 30 ug, 60 ug, or 90 ug of STP705. Enrollment will be temporarily stopped after the 40th subject. Interim Analysis will be done for dose response assessment and selection of the 2 doses for Part 2 of the study.

Part 2: 60 additional subjects will be randomized in a 1:1:1 ratio to receive placebo or one of the 2 selected STP705 doses.

This is a double-blind study. All subjects, investigators, and site staff (except unblinded pharmacist or designated site staff) in the study will be blinded to the treatment assignment.

A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).

Change in size of the treated isSCC lesion over the 6-week treatment period.

Sirnaomics

Eye Diseases

Rare Diseases

Melanoma

Nevus, Pigmented

Adenocarcinoma, Sebaceous

Eye Neoplasms

Nevus

Adenocarcinoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Diseases

Neoplasms, Adnexal and Skin Appendage

Neuroendocrine Tumor

Neuroepithelioma

Patients diagnosed with melanoma or/and nevus on the skin around the eye before surgery.

Patients diagnosed with basal cell carcinoma, squamous cell carcinoma, sebaceous gland carcinoma before surgery.

Chun Zhang, MD/PHD

Defu Wu, master

The purpose of this study is to establish a standardized process for obtaining digital pathological image information of ocular tumors; use modern pathological techniques to obtain the co-expression information of multiple biomarkers in the pathological tissues of ocular tumors, and finally construct standardized digital ocular tumors with biomarkers Pathology image database.

This study is a prospective study. Patients with common and representative ocular tumors in the Department of Ophthalmology, Peking University Third Hospital, will be selected and enrolled after informed consent to collect basic clinical information, preoperative blood samples, and ocular tumors Obtain pathological image annotation data and genomics-related data from ocular tumor tissue specimens, use blood samples for genomics information analysis, provide multi-dimensional data for the development of artificial intelligence algorithms, and establish artificial intelligence-assisted image data for eye tumors Standardize the process and establish a multi-modal ocular tumor standardized database of "clinical information-tissue samples-pathological images-genomics data". The database and the diagnosis system are correlated with each other to provide optimal image data for later machine learning and related algorithm establishment, and finally the investigators will be completed the design of a new artificial intelligence-assisted diagnosis system for eye tumors.

After the blood samples are treated with EDTA anti coagulation, the second-generation sequencing is performed from the DNA level and the RNA level to collect relevant genomics information, and establish an ocular tumor fusion genome database. Investigators will establish a complete sequencing data annotation database based on the existing tumor sequencing data annotation and analysis of soft nail sets and tumor sequencing data related public databases (such as the cosmic database).

Research of Pathological Imaging Diagnosis of Ocular Tumors Based on New Artificial Intelligence Algorithm

The result of OPAL automatic analysis will be compared with IHC manual counting analysis.The accuracy of the study will be declared "success" if OPAL automatic analysis meet more than 85% of the manual count for all antibody.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer	NCT05381597	Superficial Bas... Squamous Cell C...	Combination cre... 5-fluorouracil ...	18 Years -	Boston University
Pilot Study of PDL to Treat BCC and SCCIS	NCT01245972	Basal Cell Carc... Squamous Cell C...	PDL Treatment	18 Years -	University of California, San Diego
Pilot Study of PDL to Treat BCC and SCCIS	NCT01245972	Basal Cell Carc... Squamous Cell C...	PDL Treatment	18 Years -	University of California, San Diego
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)	NCT06159842	Facial Cutaneou...	Aminolevulinic ...	18 Years -	The Center for Clinical and Cosmetic Research
Pilot Study of PDL to Treat BCC and SCCIS	NCT01245972	Basal Cell Carc... Squamous Cell C...	PDL Treatment	18 Years -	University of California, San Diego
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)	NCT06159842	Facial Cutaneou...	Aminolevulinic ...	18 Years -	The Center for Clinical and Cosmetic Research
A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC	NCT04844983	Squamous Cell C...	STP705 Placebo Saline	18 Years -	Sirnaomics
Research of Pathological Imaging Diagnosis of Ocular Tumors Based on New Artificial Intelligence Algorithm	NCT04695015	Melanoma (Skin) Melanoma in Sit... Nevus Eye Sebaceous Gland... Basal Cell Carc... Squamous Cell C... Ocular Tumor		-	Peking University

Spots Global Cancer Trial Database for squamous cell carcinoma in situ