Melanoma; Renal Cell CarcinomaNCT03728842
Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma
An observational study of Melanoma; Renal Cell Carcinoma, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma; Renal Cell Carcinoma
- What is being tested?
- Blood collection for laboratory studies and Data collection from medical record
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2004to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic melanoma and renal cell cancer and spontaneous regression.
Who may be able to join
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.
- Willingness to undergo phlebotomy for research blood samples
Who cannot join
- 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
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
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
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.
Read the 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.
- Conditions
- Melanoma; Renal Cell Carcinoma
- Being tested
- Blood collection for laboratory studies, Data collection from medical record
- Keywords
- metastatic disease, spontaneous regression
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Neoplasm Metastasis, Remission, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection for laboratory studiesOther
Peripheral whole blood will be collected
Data collection from medical recordOther
Clinical data such as demographics and cancer characteristics, history and treatment will be collected
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous regression | Patients must have metastatic melanoma or renal cell cancer with spontaneous regression. Receives: Other: Blood collection for laboratory studies; Other: Data collection from medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood samples collected
samples collected from metastatic melanoma and renal cell cancer patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start4 Jan 2004
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma; Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Logan, Indiana University
- Investigators
- Theodore Logan, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728842
- Sponsor's protocol ID
- IUCRO-0042
- Other IDs
- 1011003667
- Status last verified
- Oct 2025
- First submitted
- 5 Oct 2018
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03728842
- Acronym / sponsor ID
- IUCRO-0042
- Conditions
- Melanoma; Renal Cell Carcinoma
- Keywords
- metastatic disease, spontaneous regression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 4 Jan 2004 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous regression | – | Other: Blood collection for laboratory studies, Other: Data collection from medical recordPatients must have metastatic melanoma or renal cell cancer with spontaneous regression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic melanoma and renal cell cancer and spontaneous regression.
Key inclusion criteria (4 listed)
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.
- Willingness to undergo phlebotomy for research blood samples
Key exclusion criteria (2 listed)
- 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
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection for laboratory studiesPeripheral whole blood will be collected | Other | Spontaneous regression |
| Data collection from medical recordClinical data such as demographics and cancer characteristics, history and treatment will be collected | Other | Spontaneous regression |
Primary outcome
Number of blood samples collected
Time frame: 1 year
samples collected from metastatic melanoma and renal cell cancer patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Logan, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma; Renal Cell Carcinoma, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blood samples collected (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.