MelanomaNCT00965861
SCRI Tissue Testing Registry
An observational study of Melanoma and Myelodysplastic Syndrome, run by SCRI Development Innovations, LLC at 1 site in United States.
Trial summary
Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Myelodysplastic Syndrome, Multiple Myeloma
- What is being tested?
- Tissue Registry Study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date.
Who may be able to join
- Patients must be >= 18 years of age.
- Patients must be able to provide written informed consent.
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
About this study
Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.
Read the detailed description
Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.
This study will consist of a registry of patients who have agreed to allow their tissue sample(s) (even those taken prior to their participation in an SCRI-sponsored trial) to be used by the SCRI Oncology Research Consortium at some point in the future for testing and analysis of expression analysis and/or analysis of tumor markers. The registry will be contained in an electronic database, and will be sorted by disease indication. (Note: Patients will not be asked to return at a future date and have tissue samples collected; rather, SCRI will have the authorization to obtain pre-existing samples).
- Conditions
- Melanoma, Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma
- Being tested
- Tissue Registry Study
- Keywords
- Tissue Registry, Tissue Collection, Unknown Primary, Breast, Lung, Gastrointestinal, Bone Marrow Transplant, Chronic Lymphocytic Leukemia, Central Nervous System, Head and Neck, Melanoma, Myelodysplastic syndrome, Multiple Myeloma, Lymphoma, Gynecologic, Genitourinary, Refractory Malignancy
- Medical subject headings
- Melanoma, Myelodysplastic Syndromes, Multiple Myeloma, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Registry StudyOther
If a patient consents to allowing the use of their tumor tissue sample(s) for testing/analysis at a future date, their name and information will be stored electronically in a registry that will be managed by SCRI. SCRI may then use the information contained in this registry (such as disease indication, demographic information, etc.) at any time in the future to select tissue samples on which to perform testing/analyses.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Receives: Other: Tissue Registry Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish an electronic registry to store information from patients who have provided their consent allowing use of their tissue sample(s) for future testing.
Measured: 120 months
To perform testing on the tissue samples to learn more about specific types of cancer and/or other diseases
Measured: 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Replaced by a study with a similar design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Burris, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965861
- Sponsor's protocol ID
- SCRI MISC 39
- Status last verified
- Aug 2013
- First submitted
- 24 Aug 2009
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCRI Tissue Testing Registry
- ClinicalTrials.gov ID
- NCT00965861
- Acronym / sponsor ID
- SCRI MISC 39
- Conditions
- Melanoma, Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma
- Keywords
- Tissue Registry, Tissue Collection, Unknown Primary, Breast, Lung, Gastrointestinal, Bone Marrow Transplant, Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Replaced by a study with a similar design.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Aug 2009 (estimated)
- 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.
Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.
Detailed description
Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.
This study will consist of a registry of patients who have agreed to allow their tissue sample(s) (even those taken prior to their participation in an SCRI-sponsored trial) to be used by the SCRI Oncology Research Consortium at some point in the future for testing and analysis of expression analysis and/or analysis of tumor markers. The registry will be contained in an electronic database, and will be sorted by disease indication. (Note: Patients will not be asked to return at a future date and have tissue samples collected; rather, SCRI will have the authorization to obtain pre-existing samples).
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Tissue Registry StudyThe SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date.
Key inclusion criteria (2 listed)
- Patients must be >= 18 years of age.
- Patients must be able to provide written informed consent.
Key exclusion criteria (1 listed)
- Not Applicable
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 |
|---|---|---|
| Tissue Registry StudyIf a patient consents to allowing the use of their tumor tissue sample(s) for testing/analysis at a future date, their name and information will be stored electronically in a registry that will be managed by SCRI. SCRI may then use the information contained in this registry (such as disease indication, demographic information, etc.) at any time in the future to select tissue samples on which to perform testing/analyses. | Other | 1 |
Primary outcome
To establish an electronic registry to store information from patients who have provided their consent allowing use of their tissue sample(s) for future testing.
Time frame: 120 months
To perform testing on the tissue samples to learn more about specific types of cancer and/or other diseases
Time frame: 120 months
Results and safety
The study was stopped early (reason given: Replaced by a study with a similar design.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
Related trials for Melanoma
RecruitingPhase 3
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
Advanced (Unresectable or Metastatic) Melanoma
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Howard Burris, M.D. study chair
SCRI Development Innovations, LLC
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 and Myelodysplastic Syndrome, run by SCRI Development Innovations, LLC 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Aug 2013. 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?
The study was stopped early (reason given: Replaced by a study with a similar design.). Results are not available in the source record.
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?
To establish an electronic registry to store information from patients who have provided their consent allowing use of their tissue sample(s) for future testing. (time frame: 120 months). The study lists 2 primary outcomes in all. 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 28 Aug 2013.