Pancreatic NeoplasmsNCT02309632
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
A study testing Pancreatic Cancer Screening Pathway 1 and Pancreatic Cancer Screening Pathway 2 in people with Pancreatic Neoplasms and Peutz-Jegher's Syndrome, run by University of Arkansas at 1 site in United States.
Trial summary
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatic Neoplasms, Peutz-Jegher's Syndrome, BRCA1 Gene Mutation
- What is being tested?
- Pancreatic Cancer Screening Pathway 1 and Pancreatic Cancer Screening Pathway 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 19 Jul 2019
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
- Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
- Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
- Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
- Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
- Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
- Patients with a known PALB2 mutation with one affected family member should be considered for screening.
- Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.
Who cannot join
- Not candidates for surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.
- Conditions
- Pancreatic Neoplasms, Peutz-Jegher's Syndrome, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ataxia Telangiectasia, Familial Atypical Mole-Malignant Melanoma Syndrome
- Being tested
- Pancreatic Cancer Screening Pathway 1, Pancreatic Cancer Screening Pathway 2
- Medical subject headings
- Pancreatic Neoplasms, Peutz-Jeghers Syndrome, Ataxia Telangiectasia, Melanoma, Cutaneous Malignant, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic Cancer Screening Pathway 1Other
Screening with imaging and biomarker testing
Pancreatic Cancer Screening Pathway 2Other
Screening with biomarker testing only
| Study group | Role | What they receive |
|---|---|---|
| Pathway 1 | Active comparator | Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1 Receives: Other: Pancreatic Cancer Screening Pathway 1 |
| Pathway2 | Active comparator | Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2 Receives: Other: Pancreatic Cancer Screening Pathway 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of PC and precancerous lesion
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startNov 2015 (estimated)
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kent D McKelvey, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309632
- Sponsor's protocol ID
- 203640
- Status last verified
- Jul 2019
- First submitted
- 3 Dec 2014
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
- ClinicalTrials.gov ID
- NCT02309632
- Acronym / sponsor ID
- 203640
- Conditions
- Pancreatic Neoplasms, Peutz-Jegher's Syndrome, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ataxia Telangiectasia, Familial Atypical Mole-Malignant Melanoma Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Nov 2015 (estimated)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 5 Dec 2014 (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.
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathway 1 | Active comparator | Other: Pancreatic Cancer Screening Pathway 1Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1 |
| Pathway2 | Active comparator | Other: Pancreatic Cancer Screening Pathway 2Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
- Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
- Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
- Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
- Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
Key exclusion criteria (1 listed)
- Not candidates for surgery
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 |
|---|---|---|
| Pancreatic Cancer Screening Pathway 1Screening with imaging and biomarker testing | Other | Pathway 1 |
| Pancreatic Cancer Screening Pathway 2Screening with biomarker testing only | Other | Pathway2 |
Primary outcome
Detection rate of PC and precancerous lesion
Time frame: 5 years
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 29 Jul 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.
Kent D McKelvey, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic Cancer Screening Pathway 1 and Pancreatic Cancer Screening Pathway 2 in people with Pancreatic Neoplasms and Peutz-Jegher's Syndrome, run by University of Arkansas 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 8 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Jul 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 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?
Detection rate of PC and precancerous lesion (time frame: 5 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 29 Jul 2019.