Gastroenteropancreatic Neuroendocrine TumorNCT02948946
Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors
An observational study of Gastroenteropancreatic Neuroendocrine Tumor and Lung Neuroendocrine Neoplasm, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor, Lung Neuroendocrine Neoplasm
- What is being tested?
- NETest
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2017to 15 Sep 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants to be enrolled in the study will be recruited within the Gastrointestinal (GI) Clinic of Moffitt Cancer Center.
Who may be able to join
- NET Cohort-
- Patients with histologically or cytologically proven diagnosis of any grade, any stage NET of GEP or lung origin; In the first stage of the study (initial 50 patients) only patients with stage IV, well-differentiated tumors (G1/G2) will be enrolled.
- Patients with stable or progressive disease, as documented on a scan (CT, MRI); Progression status will be documented on case report form (CRF).
- Allowed prior therapies include: a.) Surgery (tumor surgery at least four weeks prior to study entry); b.) Locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy at least six weeks prior to study entry; c.) Any number of previous lines of systemic therapy, providing that cytotoxic therapies (chemotherapy, PRRT) have been discontinued at least 4 weeks prior to study entry.
- Non-NET Cohort -
- Healthy participants
- Patients with histologically or cytologically proven diagnosis of any grade, any stage GI malignancies.
Who cannot join
- NET Cohort -
- Patients on treatment with cytotoxic agents (chemotherapy, PRRT).
- Patients with renal insufficiency or congestive heart failure.
- No other active malignancy within 3 years of enrolment except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission.
- Non-NET Cohort
- Patients with GI malignancies with neuroendocrine differentiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: The Clinical Utility of a Blood-Based Multitranscriptome Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors
The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest).
- Being tested
- NETest
- Keywords
- lung cancer, pancreatic cancer
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NETestProcedure or surgery
5 mL of blood will be drawn from participants for testing.
| Study group | Role | What they receive |
|---|---|---|
| Neuroendocrine Tumor (NET) Cohort | Participants with histologically or cytologically proven diagnosis of any grade, any stage NET of gastroenteropancreatic (GEP) or lung origin; In the first stage of the study (initial 50 patients) only potential participants with stage IV, well-differentiated tumors (G1/G2) will be enrolled. Receives: Procedure: NETest | |
| Non-NET Cohort | Participants with histologically or cytologically proven diagnosis of any grade, any stage gastrointestinal (GI) malignancies. Receives: Procedure: NETest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Test Results Per Cohort
Investigators have designed the study to test the null hypothesis that the NETest has a sensitivity and specificity of 70% or less in NET patients. The sample size calculation has been based on the assumption that a sensitivity and specificity of greater than 90% would generate further interest in the test for unselected NET patients. Power and type 1 error will be 99% and 5% respectively. Under this model, 80 or more positive tests in the cohort of 100 patients with NETs would lead to the rejection of the null hypothesis, suggesting that the NETest is sensitive. Likewise, 80 or more negative tests in 100 patients without NETs will suggest that NETest is specific. An interim analysis will be performed to rule out the futility of the NETest. Futility will be defined as a rate of false positive or false negative >25%. Hence, if 12 or more false positives or negatives are observed among the first 50 participants, the study will be suspended, pending review by the investigators.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start9 Jan 2017
- Primary completion24 Aug 2018
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Strosberg, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948946
- Sponsor's protocol ID
- MCC-18756
- Status last verified
- Jul 2021
- First submitted
- 27 Oct 2016
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of a Blood-Based Multitranscriptome Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02948946
- Acronym / sponsor ID
- MCC-18756
- Keywords
- lung cancer, pancreatic cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 31 Oct 2016 (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.
The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine Tumor (NET) Cohort | – | Procedure: NETestParticipants with histologically or cytologically proven diagnosis of any grade, any stage NET of gastroenteropancreatic (GEP) or lung origin; In the first stage of the study (initial 50 patients) only potential participants with stage IV, well-differentiated tumors (G1/G2) will be enrolled. |
| Non-NET Cohort | – | Procedure: NETestParticipants with histologically or cytologically proven diagnosis of any grade, any stage gastrointestinal (GI) malignancies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants to be enrolled in the study will be recruited within the Gastrointestinal (GI) Clinic of Moffitt Cancer Center.
Key inclusion criteria (7 listed)
- NET Cohort-
- Patients with histologically or cytologically proven diagnosis of any grade, any stage NET of GEP or lung origin; In the first stage of the study (initial 50 patients) only patients with stage IV, well-differentiated tumors (G1/G2) will be enrolled.
- Patients with stable or progressive disease, as documented on a scan (CT, MRI); Progression status will be documented on case report form (CRF).
- Allowed prior therapies include: a.) Surgery (tumor surgery at least four weeks prior to study entry); b.) Locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy at least six weeks prior to study entry; c.) Any number of previous lines of systemic therapy, providing that cytotoxic therapies (chemotherapy, PRRT) have been discontinued at least 4 weeks prior to study entry.
- Non-NET Cohort -
Key exclusion criteria (6 listed)
- NET Cohort -
- Patients on treatment with cytotoxic agents (chemotherapy, PRRT).
- Patients with renal insufficiency or congestive heart failure.
- No other active malignancy within 3 years of enrolment except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission.
- Non-NET Cohort
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 |
|---|---|---|
| NETest5 mL of blood will be drawn from participants for testing. | Procedure or surgery | Neuroendocrine Tumor (NET) Cohort, Non-NET Cohort |
Primary outcome
Rate of Successful Test Results Per Cohort
Time frame: 12 months
Investigators have designed the study to test the null hypothesis that the NETest has a sensitivity and specificity of 70% or less in NET patients. The sample size calculation has been based on the assumption that a sensitivity and specificity of greater than 90% would generate further interest in the test for unselected NET patients. Power and type 1 error will be 99% and 5% respectively. Under this model, 80 or more positive tests in the cohort of 100 patients with NETs would lead to the rejection of the null hypothesis, suggesting that the NETest is sensitive. Likewise, 80 or more negative tests in 100 patients without NETs will suggest that NETest is specific. An interim analysis will be performed to rule out the futility of the NETest. Futility will be defined as a rate of false positive or false negative >25%. Hence, if 12 or more false positives or negatives are observed among the first 50 participants, the study will be suspended, pending review by the investigators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
Related trials for Gastroenteropancreatic Neuroendocrine Tumor
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
RecruitingPhase 2
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2
Enrolling by invitationObservational study
Liver Transplantation Versus Conventional Medical Therapy for Low-Grade GEP-NET With Liver Metastases
Neuroendocrine Tumors
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
Not yet recruitingPhase 3
TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Gastroenteropancreatic Neuroendocrine Tumors
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.
Jonathan Strosberg, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Gastroenteropancreatic Neuroendocrine Tumor and Lung Neuroendocrine Neoplasm, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 inclusion and 6 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 4 Aug 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Successful Test Results Per Cohort (time frame: 12 months). 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 4 Aug 2021.