Gastrointestinal NeoplasmsNCT01031056
Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers
An observational study of Gastrointestinal Neoplasms and Gynecologic Cancers, run by Stanford University at 1 site in United States.
Trial summary
We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Gynecologic Cancers, Gynecologic Cancers Cervical Cancer
- What is being tested?
- Blood Draw and Frozen Tumor Specimens
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2099
- 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 with gastrointestinal cancer.
Inclusion Criteria:1. Patients are eligible if they have a histologically proven gastrointestinal cancer (esophageal, gastroesophageal junction, gastric, small intestine, appendix, colon, rectum, anus, liver, gallbladder, bile ducts, pancreas, neuroendocrine, and GI stromal tumor).
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:None
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Collection of Biospecimen and Clinical Information in Patients With Gastrointestinal Cancers
We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers.
PRIMARY OBJECTIVES:
Read more
- To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers.
SECONDARY OBJECTIVES:
- Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories
- Collect details about the tumor specimen extracted from patient charts.
- Conditions
- Gastrointestinal Neoplasms, Gynecologic Cancers, Gynecologic Cancers Cervical Cancer, Gastric (Stomach) Cancer, Gastro-Esophageal(GE) Junction Cancer, Gastrointenstinal Stromal Tumor (GIST)
- Being tested
- Blood Draw, Frozen Tumor Specimens
- Medical subject headings
- Gastrointestinal Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Anus Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Frozen Tumor SpecimensProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
None: Biospecimen will be collected for future research.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2099 (estimated)
- Study completionJan 2099 (estimated)
Why it stopped: Change in research focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Caring for Carcinoid Foundation, GI Cancer Research Gift Fund
- Responsible party
- Sponsor
- Investigators
- Teri A Longacre M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031056
- Sponsor's protocol ID
- SU-09092009-3840
- Other IDs
- GI0004
- Status last verified
- May 2012
- First submitted
- 10 Dec 2009
- Last updated
- 28 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Biospecimen and Clinical Information in Patients With Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT01031056
- Acronym / sponsor ID
- SU-09092009-3840
- Conditions
- Gastrointestinal Neoplasms, Gynecologic Cancers, Gynecologic Cancers Cervical Cancer, Gastric (Stomach) Cancer, Gastro-Esophageal(GE) Junction Cancer, Gastrointenstinal Stromal Tumor (GIST)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in research focus
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Caring for Carcinoid Foundation, GI Cancer Research Gift Fund
- Study start
- Jan 2010
- Primary completion
- Jan 2099 (estimated)
- Study completion
- Jan 2099 (estimated)
- First posted
- 14 Dec 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.
We have an active research program in gastrointestinal cancers including clinical trials, epidemiologic, and translational studies. We would like to establish a biospecimen bank linked to useful clinical information in order to learn more about diagnostic, predictive and prognostic markers for gastrointestinal cancers.
PRIMARY OBJECTIVES:
- To collect and store tumor and normal tissue (previously collected paraffin embedded or frozen specimen) and blood in patients with gastrointestinal (GI) cancers.
SECONDARY OBJECTIVES:
- Collect detailed clinical information via a patient questionnaire that includes demographic, socioeconomic, lifestyle, family, past medical, medication and cancer histories
- Collect details about the tumor specimen extracted from patient charts.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastrointestinal cancer.
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 Draw | Procedure or surgery | – |
| Frozen Tumor Specimens | Procedure or surgery | – |
Primary outcome
None: Biospecimen will be collected for future research.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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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.
Teri A Longacre M.D. 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 Gastrointestinal Neoplasms and Gynecologic Cancers, 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?
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: withdrawn, as of the sponsor's last update on 28 May 2012. 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 withdrawn before enrolling participants, so there are no results.
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?
None: Biospecimen will be collected for future research.. 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 May 2012.