AzTrials
AzTrials

Pancreatic NeoplasmPanDANCT03616431

Pancreatic Cancer Dietary Assessment Study

An observational study of Pancreatic Neoplasm and Pancreas Adenocarcinoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective observational study which aims to evaluate; The prevalence of pancreatic insufficiency in patients with pancreatic malignancies (adenocarcinoma and neuroendocrine tumours). The most appropriate diagnostic strategy. The impact that an adequate diagnosis and treatment may have on patients' outcome. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pancreo-KIT breath test
How many people
112 participants
Where
1 siteUnited Kingdom
Study dates
3 Jul 2018to 31 May 2021
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 histologically/cytologically-proven or clinically-suspected (by specialist MDT) pancreatic malignancy including pancreatic ductal adenocarcinoma or pancreatic NET.

Who may be able to join

  • Patients with histologically/cytologically-proven or clinically-suspected (by specialist MDT) pancreatic malignancy including pancreatic ductal adenocarcinoma or pancreatic NET.
  • Patients to be seen in the Medical Oncology HPB and NET team clinic for assessment
  • Age ≥18 years with no upper age limit
  • Patients must be able to give informed consent; Written consent will be required for patients to be included within the diagnostic cohort Verbal consent only will be required for patients to be included within the demographic cohort and the follow-up cohort
  • Additional cohort-specific criteria;
  • Patients will be recruited into three different cohorts with differing levels of participation (termed demographic, diagnostic and follow-up). Patients will not be recruited into the follow-up cohort until recruitment of both demographic and diagnosis cohorts are complete and the interim analysis has been performed.
Show all 9Show fewer
  • Demographic cohort | All patients referred for consideration of cancer treatment options will be eligible. Patients will need to give verbal informed consent.
  • Diagnosis cohort | Patients who are already consented for being included into the demographic cohort and who will be attending at least to one follow-up appointment and are considered to be fit enough for diagnostic assessment will be eligible. Patients will need to give written informed consent.
  • Follow-up cohort | All patients referred for consideration of options of cancer treatment will be included; patients with a minimum of 3 months of follow-up will be included in the final analysis. Patients will need to give verbal informed consent.

Who cannot join

  • As long as the inclusion criteria are fulfilled, there are no exclusion criteria.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Insufficiency in Patients With Pancreatic Malignancies

This is a prospective observational study which aims to evaluate;

The prevalence of pancreatic insufficiency in patients with pancreatic malignancies (adenocarcinoma and neuroendocrine tumours).

The most appropriate diagnostic strategy. The impact that an adequate diagnosis and treatment may have on patients' outcome.

Read the detailed description

Patients will prospectively receive a full nutritional assessment, pancreatic enzyme insufficiency (PEI) diagnosis and dietician education. This assessment will be performed as an outpatient in parallel with the medical oncology team, by the research dietician. This study will be performed in two steps (summarized in Figure 2);

Step-1 | A prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy (this will be termed 'the demographic cohort'). A sub-set of these patients (n=50) will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy (this will be termed 'the diagnosis cohort').

Step-2 | A prospective longitudinal validation of the diagnostic panel designed and tested in Step-1 and evaluation of dietician intervention (including PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, Quality of Life and overall survival (this will be termed 'the follow-up cohort' and will include up to n=50 patients).

All patients included in both steps will have a full nutritional assessment at baseline, and PERT treatment (as per standard of care if considered appropriate). Patients in the follow-up cohort will be reviewed (at least every 3 months for a maximum of 6 months since study entry) by dietician for further intervention and assessment.

Being tested
Pancreo-KIT breath test
Keywords
Pancreatic malignancy, Pancreatic enzyme insufficiency, Pancreatic enzyme replacement therapy, Pancreatic-kit breath test
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pancreo-KIT breath testDiagnostic test

    Pancreo-Kit (Isomed Pharma, Madrid, Spain) is a breath test devised to measure Pancreatic Enzyme Insufficiency. It is a non-invasive method to obtain information about the digestion of consumed lipids; this in turn is informative about the exocrine enzyme activity of the pancreas (specifically pancreatic lipase). This kit is manufactured to EC directive 98/79/EEC and carries the CE mark.

    The test is based on measurement of 13C which is a stable naturally occurring environmental isotope of carbon with a nucleus containing 6 protons and 7 neutrons (note, it is not radioactive).

Study groups in NCT03616431
Study groupRoleWhat they receive
Demographic cohortA prospective cross-sectional assessment of the prevalence of PEI-related symptoms in up to n=150 patients with pancreatic malignancy.
Diagnosis cohortA sub-set (up to n=50) of the Demographic cohort patients will be tested to elucidate the most efficient diagnostic panel for PEI in pancreatic malignancy. An extra assessment for PEI diagnosis consisting of a breath test (Pancreo-KIT breath test) will be carried out during the following 1-2 weeks after the first appointment (which takes around six hours to complete and involves the administration of bread spread with 13C butter followed by collection of the patient's breath in small plastic vials at timed intervals. The vials will subsequently be analyzed for 13C quantity; details in Appendix 6). Following these diagnostic tests, patients will complete an "acceptability questionnaire" to assess their opinion regarding the burden that these diagnostic tests may add.
Receives: Diagnostic Test: Pancreo-KIT breath test
Follow-up cohortValidation of the diagnostic panel designed and tested in Step-1 of this study and evaluation of dietician intervention (including Pancreatic Enzyme Replacement Therapy; PERT) and its impact in weight loss, symptom evolution, chemotherapy receiving rate, quality of life and overall survival.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine prevalence of pancreatic enzyme insufficiency in patients with pancreatic neoplasms.

    Prevalence will be given as a percentage of all patients with pancreatic neoplasms with evidence of pancreatic enzyme insufficiency

    Measured: 2 years

Secondary outcomes (5)

  1. To determine the prevalence of PEI-related symptoms at first oncological referral.

    Percentage of patients with documented biochemical evidence of pancreatic enzyme insufficiency with related symptoms

    Measured: 1 year

  2. To evaluate nutritional status of patients at the time of oncological referral (using a panel of 'standard of care' blood tests parameters).

    Using defined dietetic endpoints

    Measured: 1 year

  3. To assess the feasibility of performing the PEI breath test and the fecal elastase-1 measurement.

    Described as a percentage of successful tests completed by patients

    Measured: 1 year

  4. To assess, using the "acceptability questionnaire" (developed specifically for this study), the acceptability of these investigations by patients.

    To quantify acceptability on a pre-defined score for each of the tests.

    Measured: 1 year

  5. To identify, through semi structured interviews and thematic analysis, diet-related themes of interest in a subset of patients involved in this study

    Themes will be described in a semi-quantitative report arising from the interviews.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start3 Jul 2018
  3. Primary completion30 Oct 2020
  4. Study completion31 May 2021

Resources

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
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616431
Sponsor's protocol ID
15_DOG03_309
Acronym
PanDA
Status last verified
Aug 2023
First submitted
8 May 2018
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Carnie LE, Lamarca A, Vaughan K, Kapacee ZA, McCallum L, Backen A, Barriuso J, McNamara MG, Hubner RA, Abraham M, Valle JW. Prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with inoperable pancreatic malignancy (PANcreatic cancer Dietary Assessment (PanDA): a study protocol. BMJ Open. 2021 May 13;11(5):e042067. doi: 10.1136/bmjopen-2020-042067.

    PubMed 33986039

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Neoplasm and Pancreas Adenocarcinoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.

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 9 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: finished, as of the sponsor's last update on 25 Aug 2023. 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 Kingdom. 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?

Determine prevalence of pancreatic enzyme insufficiency in patients with pancreatic neoplasms. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03616431, which also lists 1 linked publication.

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 25 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in