Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma

October 24, 2025 updated by: Theodore Logan, Indiana University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic melanoma and renal cell cancer and spontaneous regression.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spontaneous regression
Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.
Other: Blood collection for laboratory studies
Peripheral whole blood will be collected
Other: Data collection from medical record
Clinical data such as demographics and cancer characteristics, history and treatment will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of blood samples collected
Time Frame: 1 year
samples collected from metastatic melanoma and renal cell cancer patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Theodore Logan, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2004

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUCRO-0042
  • 1011003667 (Other Identifier: Indiana University IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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