Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539468
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates whether active surveillance AS is a safe and comfortable alternative to standard of care SOC treatment for elderly patients with low-risk basal cell carcinoma LR-BCC Basal cell carcinoma is a type of slow-growing skin cancer that has a very low risk of spreading inside the body metastasis or death Basal cell skin cancers that are smaller across than a nickel in size and located on the trunk or limbs are particularly low risk to overall health Active surveillance - watching and not treating unless the cancer worsens - has been shown to be a generally safe way to manage LR-BCC Despite this many doctors do not feel comfortable discussing this option with patients due to a lack of studies comparing it to standard of care treatment Standard of care treatment for LR-BCC can include scrape and burn electrodesiccation and curettage surgical resection Mohs surgery and other approaches These treatments can carry risks like post-operative bleeding and wound infection and they do not always improve tumor-related quality of life Active surveillance may be a safe and comfortable alternative to SOC treatment for elderly patients with LR-BCC
Detailed Description:
PRIMARY OBJECTIVES
I To identify the baseline characteristics of patients who are willing and able to enroll in an randomized controlled trial RCT examining acceptability of AS versus vs SOC Part A II To determine if satisfaction of patients randomized to AS is noninferior to satisfaction of those randomized to SOC at one-year follow-up Part B
EXPLORATORY OBJECTIVES
I To collect additional pilot data on acceptability of AS for asymptomatic LR-BCC among the elderly
II To determine the feasibility and optimal design of a future fully powered multi-institution RCT examining the hypothesis that active surveillance of biopsy-proven low-risk BCC is an acceptable alternative to standard treatment
III To collect pilot data on clinical outcomes of AS versus SOC for asymptomatic LR-BCC among the elderly for a duration of one year the typical interval for skin cancer screening examinations for patients with a history of skin cancer
IV To compare the effects of AS vs SOC for LR-BCC among the elderly on healthcare utilization
V To identify baseline characteristics that may predict a positive experience with AS
VI To explore perceived benefits of and concerns regarding participation in the RCT among the study population
VII To explore perceived benefits of and concerns regarding AS for LR-BCC among the study population
VIII To explore causes of nonadherence to maintenance of randomization in part B
IX To explore causes of nonadherence to follow-up in part B
OUTLINE
PART A Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study
PART B Patients are randomized to 1 of 2 arms - as below and complete a standard 1-year follow-up total body skin examination followed by a second survey
ARM 1 Patients receive no treatment and undergo active surveillance over 1 year in the absence of disease progression Patients may choose to undergo treatment at any point on study
ARM 2 Patients receive SOC treatment which typically includes either electrodesiccation and curettage surgical resection or Mohs surgery as agreed upon by patient and provider in the absence of disease progression
I To identify the baseline characteristics of patients who are willing and able to enroll in an randomized controlled trial RCT examining acceptability of AS versus vs SOC Part A II To determine if satisfaction of patients randomized to AS is noninferior to satisfaction of those randomized to SOC at one-year follow-up Part B
EXPLORATORY OBJECTIVES
I To collect additional pilot data on acceptability of AS for asymptomatic LR-BCC among the elderly
II To determine the feasibility and optimal design of a future fully powered multi-institution RCT examining the hypothesis that active surveillance of biopsy-proven low-risk BCC is an acceptable alternative to standard treatment
III To collect pilot data on clinical outcomes of AS versus SOC for asymptomatic LR-BCC among the elderly for a duration of one year the typical interval for skin cancer screening examinations for patients with a history of skin cancer
IV To compare the effects of AS vs SOC for LR-BCC among the elderly on healthcare utilization
V To identify baseline characteristics that may predict a positive experience with AS
VI To explore perceived benefits of and concerns regarding participation in the RCT among the study population
VII To explore perceived benefits of and concerns regarding AS for LR-BCC among the study population
VIII To explore causes of nonadherence to maintenance of randomization in part B
IX To explore causes of nonadherence to follow-up in part B
OUTLINE
PART A Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study
PART B Patients are randomized to 1 of 2 arms - as below and complete a standard 1-year follow-up total body skin examination followed by a second survey
ARM 1 Patients receive no treatment and undergo active surveillance over 1 year in the absence of disease progression Patients may choose to undergo treatment at any point on study
ARM 2 Patients receive SOC treatment which typically includes either electrodesiccation and curettage surgical resection or Mohs surgery as agreed upon by patient and provider in the absence of disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None