Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma

Melanoma; Renal Cell Carcinoma Clinical Trial

Official title:

Blood Drawing for Study of Peripheral Blood T-lymphocytes and Other Parameters in Patients With Metastatic Melanoma and Renal Cell Cancer With Spontaneous Regression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03728842
• Other study ID #: IUCRO-0042
• Secondary ID: 1011003667
• Status: Active, not recruiting
• Start date: January 4, 2004
• Est. completion date: March 1, 2027

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect blood and clinical data from patients with metastatic melanoma and renal cell cancer who have experienced spontaneous regression for studies of immune response and other factors that may influence these occurrences.

Description:

Spontaneous regression in patients with metastatic cancer is an incredibly rare event. It has been described after infection in cancer patients and also rarely in patients with renal cell cancer (usually after resection of the renal primary) and, less commonly, in patients with metastatic melanoma.

Primary Objective To collect peripheral blood from patients with metastatic melanoma and renal cell cancer and spontaneous regression for studies of immune response and other studies.

Secondary Objective To collect clinical data from subjects registered to this study. Clinical data collection will include demographics and cancer characteristics, history and treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. = 18 years old at the time of informed consent

2. Ability to provide written informed consent and HIPAA authorization

3. Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.

4. Willingness to undergo phlebotomy for research blood samples

Exclusion Criteria

1. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety

2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Melanoma
• Melanoma; Renal Cell Carcinoma

Intervention

Other:
• Blood collection for laboratory studies
Peripheral whole blood will be collected
• Data collection from medical record
Clinical data such as demographics and cancer characteristics, history and treatment will be collected

Locations

Country	Name	City	State
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blood samples collected	samples collected from metastatic melanoma and renal cell cancer patients	1 year