NeoplasmsNCT02587026
Biorepository for Precision Genomics
An observational study of Neoplasms, run by Indiana University at 2 sites in United States.
Trial summary
This is a tissue collection protocol to create an annotated biorepository to support future basic and translational research. The study protocol and consent will request patient permission to allow their specimens to be stored for future use in other laboratory/correlative studies without requiring a separate new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Blood sample collection and Tumor tissue sample collection
- How many people
- 480 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2015to 7 Jul 2020
- How long will I take part?
- 80 Years
- 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: Patients who attend the Precision Genomics Clinic at Indiana University Health may elect to participate in this tissue and blood collection protocol.
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 histologically or cytologically confirmed malignancy or related disorder. This includes patients with active disease as well as those in remission.
- One of the following tissue collection situations
- Group 1: Patients having tissue collection for clinical reasons who are willing to have additional specimens taken for research (biopsy may be done under local anesthesia, intravenous conscious sedation, or general anesthesia, as clinically indicated)
- Group 2: Patients willing to undergo tissue collection for the purpose of research only (biopsy may be done under local anesthesia or intravenous conscious sedation per the judgment of the treating physician). This may include collection of additional samples from patients undergoing a study-specific research biopsy/procedure. Patients in group 2 may not undergo general anesthesia as part of this protocol.
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- Group 3: Patients having tissue collection for clinical reasons who are willing to have excess tissue (i.e., tissue that would have otherwise been discarded) banked for research (biopsy may be done under local anesthesia, intravenous conscious sedation, or general anesthesia, as clinically indicated).
- Willingness to undergo phlebotomy for research blood samples Additional Criteria for Patients in Groups 1 and 2
- PT and PTT levels < 1.2 x the institutional ULN (PT, PTT not required for skin biopsies)
- Not receiving therapeutic anticoagulation
- Platelets ≥ 100 x 109/L
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.
- History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
- Any other condition, which in the opinion of the patient's treating oncologist or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
- Additional Criteria for Patients in Group 1 and 2
- Pregnant women are excluded from Groups 1 and 2 because there may be an increased risk to both mother and fetus in the setting of conscious sedation, which is required for biopsies of certain anatomic sites (e.g. liver, lung, bone). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.
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- Patients in Groups 1 and 2 may not have active cardiac disease, defined as:
- History of uncontrolled or symptomatic angina
- History of arrhythmias requiring medications, or clinically significant
- Myocardial infarction < 6 months from study entry
- Uncontrolled or symptomatic congestive heart failure
- Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- Patients in group 1 and 2 receiving bevacizumab or other angiogenesis inhibitors (or less than 6 weeks from last dose of an angiogenesis inhibitor) should not undergo a research core liver biopsy on this protocol because of the concern for the possibility of increased bleeding risk. Patients may undergo a research fine needle aspiration (FNA) of the liver as an alternative. Patients may also undergo core research biopsies of other sites, up to the discretion of the treating physician, but physicians should take the potential increased bleeding and/or delayed wound healing issues into consideration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Ball Memorial
Muncie, Indiana, 47303
About this study
Official title: Collection of Specimens and Clinical Data to Create a Biorepository for Precision Genomics
This is a tissue collection protocol to create an annotated biorepository to support future basic and translational research. The study protocol and consent will request patient permission to allow their specimens to be stored for future use in other laboratory/correlative studies without requiring a separate new consent at a future date. It will include also a retrospective review of all patients who have been seen or treated by the Precision Genomics Clinic (waiver of consent requested). No specific research studies/aims are included directly in this proposal. Use of the samples, data, and other resources (cell lines, etc.) created within this protocol will require review/approval by the majority of the Precision Genomics Investigators and appropriate IRB approval.
- Conditions
- Neoplasms
- Being tested
- Blood sample collection, Tumor tissue sample collection
- Keywords
- Biorepository, Precision Genomics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Tumor tissue sample collectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Biorepository for precision genomics
Blood and tissue sample collection for use in future basic and translational research studies
Measured: From time of patient consent (day 1) to time of sample collection (which can occur on day 1-day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start27 Aug 2015
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Why it stopped: Study team has decided to close enrollment, and all subjects are being rolled into a different clinical trial: Total Cancer Care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Time perspective
- Other
- Enrolment
- 480 participants (actual)
- Target duration
- 80 Years
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Schneider, Indiana University
- Investigators
- Bryan P Schneider, MD, Principal investigator, Vera Bradley Professor of Oncology, Professor of Medicine, Professor of Medical & Molecular Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587026
- Sponsor's protocol ID
- IUSCC-0534
- Status last verified
- Nov 2020
- First submitted
- 8 Oct 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Specimens and Clinical Data to Create a Biorepository for Precision Genomics
- ClinicalTrials.gov ID
- NCT02587026
- Acronym / sponsor ID
- IUSCC-0534
- Conditions
- Neoplasms
- Keywords
- Biorepository, Precision Genomics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study team has decided to close enrollment, and all subjects are being rolled into a different clinical trial: Total Cancer Care
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 27 Oct 2015 (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.
This is a tissue collection protocol to create an annotated biorepository to support future basic and translational research. The study protocol and consent will request patient permission to allow their specimens to be stored for future use in other laboratory/correlative studies without requiring a separate new consent at a future date. It will include also a retrospective review of all patients who have been seen or treated by the Precision Genomics Clinic (waiver of consent requested). No specific research studies/aims are included directly in this proposal. Use of the samples, data, and other resources (cell lines, etc.) created within this protocol will require review/approval by the majority of the Precision Genomics Investigators and appropriate IRB approval.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 80 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who attend the Precision Genomics Clinic at Indiana University Health may elect to participate in this tissue and blood collection protocol.
Key inclusion criteria (11 listed)
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Patients must have histologically or cytologically confirmed malignancy or related disorder. This includes patients with active disease as well as those in remission.
- One of the following tissue collection situations
- Willingness to undergo phlebotomy for research blood samples Additional Criteria for Patients in Groups 1 and 2
Key exclusion criteria (13 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.
- History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
- Any other condition, which in the opinion of the patient's treating oncologist or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
- Additional Criteria for Patients in Group 1 and 2
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 sample collection | Other | – |
| Tumor tissue sample collection | Other | – |
Primary outcome
Biorepository for precision genomics
Time frame: From time of patient consent (day 1) to time of sample collection (which can occur on day 1-day 35)
Blood and tissue sample collection for use in future basic and translational research studies
Results and safety
The study was stopped early (reason given: Study team has decided to close enrollment, and all subjects are being rolled into a different clinical trial: Total Cancer Care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Bryan P Schneider, MD principal investigator
Vera Bradley Professor of Oncology, Professor of Medicine, Professor of Medical & Molecular Genetics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Indiana University at 2 sites 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 11 inclusion and 13 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Study team has decided to close enrollment, and all subjects are being rolled into a different clinical trial: Total Cancer Care). 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?
Biorepository for precision genomics (time frame: From time of patient consent (day 1) to time of sample collection (which can occur on day 1-day 35)). 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 13 Nov 2020.