NeoplasmNCT01457196
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
A study testing Tumor Genetic Sequencing in people with Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm
- What is being tested?
- Tumor Genetic Sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,798 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 6 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
- Tumor tissue available and suitable for molecular analyses from at least one of the following sources:
- Tissue previously stored in UNC's Tissue Procurement Facility (TPF)
- Tissue previous stored at an institution other than UNC-CH, provided investigators can determine that the tumors were sampled and stored under appropriate conditions for inclusion in the study
- Patient undergoing tissue collection as per clinical standard of care and willing to allow specimens from surplus tissue to be diverted for research purposes
- Patient undergoing tissue collection as per clinical standard of care and willing to have additional specimens taken for research
Show all 11Show fewer
- Patient willing to undergo biopsy for purpose of research only
- The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol:
- ≥18 years of age
- Treatment options offer no expectation of cure, e.g., advanced solid tumor patients with metastatic disease. NOTE: This restriction applies to biopsy of vital organs only, e.g., lung, liver, etc.
- Appropriate candidate for research biopsy based on institutional standards for target biopsy site
Who cannot join
- Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
- Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
- The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
- History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
- Requires general anesthesia for collection of biopsy
- Pregnant or lactating women
- Active cardiac disease
- Patients receiving bevacizumab less than 6 weeks prior to enrollment into this study should not undergo research core biopsies because of the concern for potential increased bleeding risk and delayed healing. (NOTE: Patients receiving bevacizumab who are undergoing a research biopsy of accessible organs (e.g. breast, lymph node, skin etc.) must be two weeks from the last dose of the angiogenesis inhibitor).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.
- Conditions
- Neoplasm
- Being tested
- Tumor Genetic Sequencing
- Keywords
- Cancer Genetics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Genetic SequencingDiagnostic test
This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.
| Study group | Role | What they receive |
|---|---|---|
| Sequencing Arm | Other | Not described Receives: Diagnostic Test: Tumor Genetic Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With a Reportable Genetic Variant
To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified
Measured: 1 year
Progression Free Survival
Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant
Measured: 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startSep 2011
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H. Shelton Earp, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457196
- Sponsor's protocol ID
- LCCC1108
- Status last verified
- Dec 2019
- First submitted
- 13 Oct 2011
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
- ClinicalTrials.gov ID
- NCT01457196
- Acronym / sponsor ID
- LCCC1108
- Conditions
- Neoplasm
- Keywords
- Cancer Genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,798 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequencing Arm | Other | Diagnostic Test: Tumor Genetic Sequencing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
- Tumor tissue available and suitable for molecular analyses from at least one of the following sources:
- The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol:
Key exclusion criteria (8 listed)
- Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
- Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
- The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
- History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
- Requires general anesthesia for collection of biopsy
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 |
|---|---|---|
| Tumor Genetic SequencingThis study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer. | Diagnostic test | Sequencing Arm |
Primary outcome
Proportion of Patients With a Reportable Genetic Variant
Time frame: 1 year
To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified
Progression Free Survival
Time frame: 2 Year
Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
H. Shelton Earp, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Genetic Sequencing in people with Neoplasm, run by UNC Lineberger Comprehensive Cancer Center 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 30 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With a Reportable Genetic Variant (time frame: 1 year). 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 30 Dec 2019.