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Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728842
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Theodore Logan, Indiana University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Melanoma; Renal Cell Carcinoma Other: Blood collection for laboratory studies Other: Data collection from medical record

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 24, 2003
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021


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




Primary Outcome Measures :
  1. Number of blood samples collected [ Time Frame: 1 year ]
    samples collected from metastatic melanoma and renal cell cancer patients


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic melanoma and renal cell cancer and spontaneous regression.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728842


Contacts
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Contact: Theodore Logan, MD 317-948-7576 tlogan@iu.edu

Locations
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United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sheila Dropcho, RN    317-278-4191    sdropcho@iupui.edu   
Principal Investigator: Theodore Logan, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Theodore Logan, MD Indiana University School of Medicine
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Responsible Party: Theodore Logan, Associate Professor of Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT03728842    
Other Study ID Numbers: IUCRO-0042
1011003667 ( Other Identifier: Indiana University IRB )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theodore Logan, Indiana University School of Medicine:
metastatic disease
spontaneous regression
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases