Pancreatic CancerNCT00898482
Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants
An observational study of Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future. PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- This is a non-intervention study for all groups. and study of socioeconomic and demographic variables
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jun 2011
- 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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The three cohorts are: 1) Healthy individuals, 2) At risk individuals and 3) Cancer patients.
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Histologically confirmed pancreatic malignant neoplasm
- Serologically or image-confirmed diagnosis of pancreatitis or nonmalignant pancreatic disease
- Healthy, at-risk participant meeting the following criteria:
- Smoker, diabetic, and/or has a family history of pancreatic cancer
- Healthy participant (no history of cancer)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository
RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future.
PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.
Read the detailed description
OBJECTIVES:
- Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies.
- Utilize the clinical database to perform clinicopathologic correlation with the results of those studies.
- Test new hypotheses as they emerge.
OUTLINE: This is a prospective study.
Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored.
PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- This is a non-intervention study for all groups., study of socioeconomic and demographic variables
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-intervention study for all groups.Other
This is a non-intervention study.
study of socioeconomic and demographic variablesOther
Non-intervention study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Not described Receives: Other: This is a non-intervention study for all groups.; Other: study of socioeconomic and demographic variables | |
| At risk individuals | Not described Receives: Other: This is a non-intervention study for all groups.; Other: study of socioeconomic and demographic variables | |
| Cancer patients | Not described Receives: Other: This is a non-intervention study for all groups.; Other: study of socioeconomic and demographic variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a central pancreatic cancer specimen repository
Measured: No time frame
Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies
Measured: No time frame
Test new hypotheses as they emerge
Measured: No time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Case only
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel A. Laheru, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898482
- Sponsor's protocol ID
- JHOC-J0533 CDR0000452792
- Other IDs
- P30CA006973, JHOC-J0533, JHOC-05042601
- Status last verified
- Nov 2015
- First submitted
- 9 May 2009
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository
- ClinicalTrials.gov ID
- NCT00898482
- Acronym / sponsor ID
- JHOC-J0533 CDR0000452792
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 May 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.
RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future.
PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.
Detailed description
OBJECTIVES:
- Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies.
- Utilize the clinical database to perform clinicopathologic correlation with the results of those studies.
- Test new hypotheses as they emerge.
OUTLINE: This is a prospective study.
Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored.
PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.
Study design
- Observational model
- Case only
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Other: This is a non-intervention study for all groups., Other: study of socioeconomic and demographic variables |
| At risk individuals | – | Other: This is a non-intervention study for all groups., Other: study of socioeconomic and demographic variables |
| Cancer patients | – | Other: This is a non-intervention study for all groups., Other: study of socioeconomic and demographic variables |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The three cohorts are: 1) Healthy individuals, 2) At risk individuals and 3) Cancer patients.
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 |
|---|---|---|
| This is a non-intervention study for all groups.This is a non-intervention study. | Other | At risk individuals, Cancer patients, Healthy individuals |
| study of socioeconomic and demographic variablesNon-intervention study. | Other | At risk individuals, Cancer patients, Healthy individuals |
Primary outcome
Establishment of a central pancreatic cancer specimen repository
Time frame: No time frame
Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies
Time frame: No time frame
Test new hypotheses as they emerge
Time frame: No time frame
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 20 Nov 2015.
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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.
Daniel A. Laheru, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Establishment of a central pancreatic cancer specimen repository (time frame: No time frame). The study lists 3 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 20 Nov 2015.