Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma

NCT ID: NCT03728842

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-04

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma; Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spontaneous regression

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

Blood collection for laboratory studies

Intervention Type OTHER

Peripheral whole blood will be collected

Data collection from medical record

Intervention Type OTHER

Clinical data such as demographics and cancer characteristics, history and treatment will be collected

Interventions

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Blood collection for laboratory studies

Peripheral whole blood will be collected

Intervention Type OTHER

Data collection from medical record

Clinical data such as demographics and cancer characteristics, history and treatment will be collected

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Theodore Logan

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theodore Logan, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1011003667

Identifier Type: OTHER

Identifier Source: secondary_id

IUCRO-0042

Identifier Type: -

Identifier Source: org_study_id

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