PDT for Carcinoma, Basal Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, OH
Carcinoma, Basal Cell+2 More
PDT - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether PDT alters the immune response to BCC.

See full description

Eligible Conditions

  • Carcinoma, Basal Cell
  • Carcinoma, Basal Cell (BCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Basal Cell

Study Objectives

This trial is evaluating whether PDT will improve 3 primary outcomes and 8 secondary outcomes in patients with Carcinoma, Basal Cell. Measurement will happen over the course of Every 30 minutes up to 4 hours.

Hour 4
Maximal PpIX levels in tumors
Rate of protoporphyrin IX (PpIX) accumulation in tumors
Day 14
Change in the appearance of tumors
Change in the color of tumors
Change in the volume of tumors
To determine the relationship of PDT with the expression of immune- and cancer-associated RNA molecules
Day 14
Altered expression of immune checkpoint molecules
Altered recruitment of different immune cell subtypes in BCC tumor specimens
Distant tumor (abscopal) effects after PDT
Proportion of tumor-activated CD8+ T-cells after PDT
Time to maximum expression of immune checkpoint molecules

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma, Basal Cell

Trial Design

1 Treatment Group

Photodynamic therapy (PDT)
1 of 1
Experimental Treatment

This trial requires 28 total participants across 1 different treatment group

This trial involves a single treatment. PDT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Photodynamic therapy (PDT)Each participant will serve as their own control, receiving PDT for one tumor, no PDT for the second tumor (untreated control). Visit 1: Informed consent Blood draw Lesion(s) Photographed (ALA) applied for4 hours PpIX measured in lesions (PpIX buildup monitored every 30 minutes over a 4 h period) PDT with blue light Visit 2 (scheduled for within one of the following time intervals: 1-3 days, 4-7 days, or 8-14 days post-PDT): Blood draw Lesion(s) Photographed Mohs surgery After procedure, excess frozen BCC tissue will be saved for analysis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aminolevulinic acid
FDA approved
PDT
2013
Completed Phase 4
~350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at visit 1 (pre pdt) and visit 2 (1-14 days)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at visit 1 (pre pdt) and visit 2 (1-14 days) for reporting.

Closest Location

Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults scheduled to undergo Mohs surgery within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic
Must have at least two BCC tumors eligible for removal by Mohs surgery
Men and women of any ethnic group are eligible
Must provide informed consent to participate

Patient Q&A Section

Does carcinoma run in families?

"Although our results suggest that familial aggregation exists for some cancers, we found no evidence of significant linkage between hereditary breast/ovarian cancer and any specific gene loci. Further studies are needed to explore the relationship between familial cancer and other genes. The ability to identify such genes will facilitate the development of effective diagnostic and preventive methods for hereditary cancers." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pdt?

"Although it was only observed in one small cohort, we believe that pdt may be useful as a novel therapeutic agent for patients with lung carcinoma." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"Carcinoma may be caused by viral infections (e.g., HPV 16, 18, and 45), bacterial infections (e.g., salmonella, Shiga toxin 1, and bacillus Calmette-Guérin), environmental agents, and hereditary factors (e.g., hereditary nonpolyposis colorectal cancer).\n" - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma spread?

"Different metastatic sites occurred at different times in the disease course; lung, liver, bone, brain, and adrenal were the most common sites of metastases. The distribution of metastases suggested that pulmonary dissemination was more frequent than extrapulmonary dissemination. Recent findings indicated that the incidence of distant metastasis is not constant over time but rather seems to change during the cancer progression process." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma?

"The 5-year survival rate of carcinoma in situ was 22%, which was lower than the 94% 5-year survival rate for invasive carcinoma. Even though this difference was statistically significant, it did not appear to be clinically significant. The survival rate for carcinoma depends largely on the stage at diagnosis; however, the grade of differentiation has a much greater effect on the prognosis of carcinoma." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma?

"The study concluded that the survival rate for node negative carcinoma patients increased up to 5 years after diagnosis instead of 1 year. For node positive carcinoma patients, the survival rate increased till 2 years after diagnosis but then decreased over 3 years. The survival rate was unaffected by other factors such as gender, stage, and biological subtype of carcinoma. Cancer 2015;121:842-850. © 2015 American Cancer Society." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma?

"In a recent study, the mean age at cancer onset was 56.6 years. The percentage of cases occurring during menopause was 32.8%, which suggests that early detection campaigns might benefit women more than men." - Anonymous Online Contributor

Unverified Answer

How does pdt work?

"The pdt protein shows a strong correlation with angiogenesis, tumor cell proliferation, and metastasis. Therefore, pdt could be an attractive target for antiangiogenic cancer therapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma?

"The signs of carcinoma are nonspecific but commonly include skin changes (rough, scaly patches) and weight loss. They can produce similar clinical presentations to those seen in inflammatory conditions, including hyperlipaemia, arthritis and dermatitis." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma?

"Recent findings suggest that [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) may be the result of numerous environmental factors that are not disclosed by our current understanding of its etiology. Recent findings may explain why we see a large number of cancers, including breast cancer, occurring among the same group of women." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma?

"Recent findings of this survey suggest that the majority of clinicians think that participation in clinical trials for carcinoma is beneficial and would be willing to consider participating in a clinical trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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