CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0012056: Cutaneous melanomaHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug1259 Ipilimumab Wiki 0.58
drug121 Active control:Healthy Living Wiki 0.58
drug1068 Home sample collection of concerning mole with physician supervision Wiki 0.58
drug2170 SSE educational intervention Wiki 0.58
drug2062 Relatlimab Wiki 0.41
drug2389 Survey Administration Wiki 0.41

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D008545 Melanoma NIH 1.00

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 3 clinical trials

Clinical Trials


1 A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

NCT03978611 Melanoma Drug: Relatlimab Drug: Ipilimumab
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

Primary Outcomes

Measure: Number of Participants with Adverse Events (AEs)

Time: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

Measure: Number of Participants with Serious Adverse Events (SAEs)

Time: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

Measure: Number of Participants With Adverse Events Including Dose Limiting Toxicity

Time: Up to 28 days after last study drug dose (approximately up to 2 years)

Measure: Number of Participants with AEs resulting in Discontinuation

Time: Up to end of study (approximately 2.4 years)

Measure: Number of Participants with AEs resulting in Death

Time: Up to end of study (approximately 2.4 years)

Measure: Number of Participants with AEs resulting in Laboratory Abnormalities

Time: Up to end of study (approximately 2.4 years)

Measure: Objective Response Rate (ORR)

Time: Approximately 2.4 years

Secondary Outcomes

Measure: Duration of response (DOR)

Time: Approximately Up to 2.4 years

Measure: Median PFS

Time: 6 and 12 months

Measure: Median Overall Survival (OS)

Time: 1 and 2 years

Measure: Number of Participants with Anti-Drug Antibodies (ADA)-Positivity

Time: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

Description: Progression free survival rates (PFS rates)

Measure: Progression Free Survival rates (PFS rates)

Time: at 24 weeks and at 1 year

Description: Overall Survival Rates (OS rates)

Measure: Overall Survival Rates (OS rates)

Time: at 1 year and at 2 years

Description: Objective Response Rate (ORR)

Measure: Objective Response Rate (ORR)

Time: up to 2.4 years

2 Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter

The purpose of this study is to reduce melanoma mortality by improving early detection of melanoma with skin self-examination (SSE) among people who self-identify as being at risk and seek care for a concerning mole. Because women are more likely than men to perform SSE, women who are engaged in health promotion by having a recent screening mammogram are the focus of this research. Self-management of melanoma detection with SSE depends on ready access to dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home order (COVID-19) prohibited non-essential health care, including screening mammography and dermatology office-based care, and both are expected to remain limited until fall 2020. This submission explores a) the effectiveness of targeted melanoma detection (TMD) among women, who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b) the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule out melanoma in moles identified by women as concerning.

NCT04420273 Melanoma Behavioral: SSE educational intervention Other: Home sample collection of concerning mole with physician supervision Behavioral: Active control:Healthy Living
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

Primary Outcomes

Description: Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey

Measure: Change in SSE performance

Time: 90 days

Description: Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.

Measure: Identification of concerning mole

Time: 90 days

Description: The quantity of cells obtained for genomic analysis will be assessed. The results of the genomic analysis will be validated with the pathological findings of the biopsied concerning mole. A Student t test will be performed for the null hypothesis of no difference between the genomic analysis and the pathological finding of melanoma.

Measure: Effectiveness of adhesive patch-based home sample collection for genomic analysis of concerning moles to rule-out melanoma

Time: 90 Days

Secondary Outcomes

Description: Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score= more anxiety

Measure: Change in skin self-examination anxiety

Time: 90 days

Description: Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence.

Measure: Change in confidence performing mole checks

Time: 90 days

Description: Electronic medical record review

Measure: Number of physician visits for concerning moles

Time: 5 months

Description: Electronic medical record review

Measure: Number of biopsies of concerning moles

Time: 5 months

3 Well-Being and Quality of Life in Melanoma Patients During COVID-19 Pandemic

The primary purpose of this study is to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of health-related quality of life and other areas such as COVID-19 specific psychological distress, and disruptions to health care, finances and social interactions. We will also evaluate the extent to which resiliency factors such as social support, perceived benefits under times of stress, and ability to manage stress may buffer associations between COVID-19 experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire that taps into these areas and is based on prior work addressing concerns of other pandemics or national crises. Participants will have previously consented to protocol PA15-0336 and have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data with prior existing data.

NCT04474301 COVID-19 Infection Melanoma Other: Survey Administration
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

Primary Outcomes

Description: Including exposure, risk factors, testing, isolation, seropositivity, hospitalization, or loss of family or friends.

Measure: Experiences during the COVID-19 pandemic

Time: Survey completion Up to 2 months

Measure: COVID-19-specific psychological distress

Time: Survey completion Up to 2 months

Measure: COVID-19-specific health

Time: Survey completion Up to 2 months

Measure: COVID-19-specific financial and social disruptions

Time: Survey completion Up to 2 months

Measure: COVID-19-specific perceived benefits and social support

Time: Survey completion Up to 2 months

Measure: COVID-19-specific health related quality of life (HRQoL)

Time: Survey completion Up to 2 months

Description: Will evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

Measure: Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL

Time: Survey completion Up to 2 months

Description: Will explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL.

Measure: Prior lifestyle data

Time: Survey completion Up to 2 months


HPO Nodes