Squamous Cell CarcinomaNCT00507702
Identification of Key Blood Molecular Markers for Immunotherapy
An observational study of Squamous Cell Carcinoma and Adenocarcinoma, run by Stanford University at 1 site in United States.
Trial summary
To identify unique blood markers in cancer patients so that we can identify patients with evidence of pre-existing immunity who may be a responder to immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Adenocarcinoma, Neoplasms
- What is being tested?
- phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2006to 25 Feb 2015
- 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: Tumors occur predominantly in the adult population after age 30, regardless of gender and ethnic background. Therefore, our study population will consist mainly of adult subjects. We do not have any exclusion criteria based on age range, gender or ethnic background.
Who may be able to join
- Patients diagnosed with cancerous tumors based on biopsy or other clinical observations.
- Patients diagnosed with non-cancerous tumors based on biopsy or other clinical observations.
- Normal volunteers who do not have cancer or other medical conditions that may affect survival.
Who cannot join
- Patients will be excluded if, upon clinical observation, they are under a severe septic or inflammatory condition. In these conditions, human body immune response against sepsis or inflammation should be the predominant response, and may shield or block the immune response against tumors.
- Patients will be excluded if, upon clinical observation, they are under extremely illness situation like myocardial infarction. In such a case, the immune findings may be altered.
- Patients will be excluded if, upon looking through their medical records, significant information required for data analysis is missing. This is because that patients' medical records will help us connect our research findings with their clinical observations, and further provide guidelines for subsequent treatment options.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To identify unique blood markers in cancer patients so that we can identify patients with evidence of pre-existing immunity who may be a responder to immunotherapy.
- Conditions
- Squamous Cell Carcinoma, Adenocarcinoma, Neoplasms
- Being tested
- phlebotomy
- Medical subject headings
- Carcinoma, Squamous Cell, Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phlebotomyProcedure or surgery
Also called blood draw
Standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and evaluate the presence of pre-existing immunity related markers in peripheral human blood, to identify patients who may respond to IL-12 immunotherapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study start6 Jul 2006
- Primary completion25 Feb 2015
- Study completion25 Feb 2015
Why it stopped: Improving assay methods
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey A. Norton, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507702
- Sponsor's protocol ID
- VAR0017
- Other IDs
- 97125, VAR0017
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2007
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Key Blood Molecular Markers for Immunotherapy
- ClinicalTrials.gov ID
- NCT00507702
- Acronym / sponsor ID
- VAR0017
- Conditions
- Squamous Cell Carcinoma, Adenocarcinoma, Neoplasms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Improving assay methods
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 6 Jul 2006 (actual)
- Primary completion
- 25 Feb 2015 (actual)
- Study completion
- 25 Feb 2015 (actual)
- First posted
- 26 Jul 2007 (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.
To identify unique blood markers in cancer patients so that we can identify patients with evidence of pre-existing immunity who may be a responder to immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tumors occur predominantly in the adult population after age 30, regardless of gender and ethnic background. Therefore, our study population will consist mainly of adult subjects. We do not have any exclusion criteria based on age range, gender or ethnic background.
Key inclusion criteria (3 listed)
- Patients diagnosed with cancerous tumors based on biopsy or other clinical observations.
- Patients diagnosed with non-cancerous tumors based on biopsy or other clinical observations.
- Normal volunteers who do not have cancer or other medical conditions that may affect survival.
Key exclusion criteria (3 listed)
- Patients will be excluded if, upon clinical observation, they are under a severe septic or inflammatory condition. In these conditions, human body immune response against sepsis or inflammation should be the predominant response, and may shield or block the immune response against tumors.
- Patients will be excluded if, upon clinical observation, they are under extremely illness situation like myocardial infarction. In such a case, the immune findings may be altered.
- Patients will be excluded if, upon looking through their medical records, significant information required for data analysis is missing. This is because that patients' medical records will help us connect our research findings with their clinical observations, and further provide guidelines for subsequent treatment options.
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 |
|---|---|---|
| phlebotomyAlso: blood drawStandard of care | Procedure or surgery | – |
Primary outcome
To identify and evaluate the presence of pre-existing immunity related markers in peripheral human blood, to identify patients who may respond to IL-12 immunotherapy
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Improving assay methods). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Jeffrey A. Norton principal investigator
Stanford 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 Squamous Cell Carcinoma and Adenocarcinoma, run by Stanford 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 3 inclusion and 3 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 18 Apr 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?
The study was stopped early (reason given: Improving assay methods). 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 identify and evaluate the presence of pre-existing immunity related markers in peripheral human blood, to identify patients who may respond to IL-12 immunotherapy (time frame: 3 years). 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 18 Apr 2019.