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Search Results

Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03728842
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Indiana University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Theodore Logan, MD
Principal Investigator Affiliation Indiana University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma; Renal Cell Carcinoma
Additional Details

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.

Arms & Interventions

Arms

: Spontaneous regression

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Indiana University Simon Cancer Center, Indianapolis, Indiana

Status

Address

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202

Nearest Location


Resources

  • Patient and Caregiver Survey
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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