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A Prospective Translational Tissue Collection Study in Early and Advanced Pancreatic Ductal Adenocarcinoma and Pancreatic Neuroendocrine Tumours to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers (PaC-MAn)

19 februari 2020 uppdaterad av: Royal Marsden NHS Foundation Trust

A Prospective Translational Tissue Collection Study in Early and Advanced Pancreatic Ductal Adenocarcinoma (PDAC) and Pancreatic Neuroendocrine Tumours (PanNETs) to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers

There are several types of early pre-cancerous lesions found in the pancreas which have the potential to develop into pancreatic cancer. Although different patients' pancreatic cancers or pre-cancerous pancreatic lesions have many similarities we believe that subtle differences can affect how they behave and therefore influence individual patient outcomes. Many factors may account for the differences seen in pancreatic lesion behaviour, for example molecular and genetic differences (the DNA and RNA present which control how a cell grows and divides), differences in how the immune system responds to the lesion, differences in the environment immediately around the lesion in the pancreas, known as the tumour microenvironment and differences in the micro-organisms which colonize a particular patient, known as their microbiota .

This project studies the molecular makeup of pancreatic lesions and their microenvironment at various stages (from pre-cancerous lesions all the way through to more advanced disease) to see if we can use this information to divide patients into different groups whose lesions may behave in similar ways. We will be trying to find out if there are molecular reasons why some patients respond to particular treatments when others do not, why some patients experience more toxicity with particular treatments and why some patients' disease behaves particularly aggressively when other patients' disease does not. We will also be investigating the particular micro-organisms colonizing individual patients to see if these impact a patient's outcome. Understanding what makes one person's pancreatic lesion behave differently to another's could lead to better treatment, where a personalized therapeutic strategy could be applied for every single patient.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

The main objective is to describe the incidence and distribution of tumour biomarkers, and to identify molecular subgroups from a multicentre series of patients who are investigated for and subsequently diagnosed with a pancreatic adenocarcinoma (PDAC) or a precursor lesion or a pancreatic neuroendocrine tumour.

The secondary objective is to determine disease control rate (CR, PR and SD >24 weeks), duration of response, progression free survival (PFS) and overall survival (OS) in locally advanced / metastatic patients or relapse free survival (RFS) and overall survival (OS) in early stage curative / pre-cursor lesion patients, associated with the identified molecular subtypes of PDAC pancreatic cancer and relevant anti-cancer therapies.

To identify molecular predictors of response or toxicity to standard of care anti-cancer therapies in PDAC/PanNET. The study also has a number of exploratory objectives listed below:

Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include:

  1. Evaluation of the predictive value of biomarker expression (i.e. the ability of a biomarker to predict responsiveness or resistance to a specific anti-cancer treatment).
  2. Evaluation of the prognostic value of biomarker expression (i.e. the ability of a biomarker to predict outcome regardless of a specific anti-cancer treatment).
  3. Comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and evaluation of their prognostic value.

Studietyp

Observationell

Inskrivning (Förväntat)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Storbritannien
    • Surrey
      • Sutton, Surrey, Storbritannien, SM2 5PT
        • Rekrytering
        • The Royal Marsden NHS Foundation Trust
        • Kontakt:
        • Underutredare:
          • David Lau

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic neuroendocrine tumour.

Beskrivning

Inclusion Criteria:

  1. Patient is being investigated or treated for pancreatic cancer or precursor lesions at The Royal Marsden Hospital and referring centres during the study period.
  2. Patient has a histologically/cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma, or pancreatic neuroendocrine tumour OR Patient has a tissue lesion suspicious for pancreatic cancer amenable to core needle biopsy or surgery and is clinically fit enough to undergo a tumour biopsy or surgery according to investigator assessment and local guidelines.
  3. Patient is ≥ 18 years of age.
  4. Patient can understand the patient information sheet and is able to provide written informed consent.
  5. Patient has sufficient tissue and/or blood and/or urine and/or stool and/or saliva sampling for analysis as per the protocol.

Exclusion Criteria:

1. Patients who are not treated at all at The Royal Marsden Hospital or referring centre.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Pancreatic Cancer
Patients who are investigated for and subsequently diagnosed with early/advanced pancreatic adenocarcinoma or a precursor lesion or a pancreatic neuroendocrine tumour.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
to describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, series of patients with pancreatic cancer and precursor lesions.
Tidsram: 4 years
Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected
4 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To describe the incidence and distribution of biomarkers and identify molecular subtypes in a large, multi-centre, population of patients with pancreatic cancer or precursor lesions.
Tidsram: 4 years
Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out.
4 years
To identify molecular predictors of response or toxicity to standard of care anti-cancer therapies in PDAC/PanNET.
Tidsram: 4 years
Blood, urine, stool, saliva, bile and tissue samples from patients undergoing a tissue biopsy or surgery for suspected or known pancreatic cancer will be collected. Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out.
4 years

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include
Tidsram: 4 years
evaluation of the predictive value of biomarker expression (i.e. the ability of a biomarker to predict responsiveness or resistance to a specific anti-cancer treatment).
4 years
Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include
Tidsram: 4 years
evaluation of the prognostic value of biomarker expression (i.e. the ability of a biomarker to predict outcome regardless of a specific anti-cancer treatment).
4 years
Depending on the number of patients assessable for each biomarker of interest and the prevalence of biomarker expression in the study population, exploratory endpoints of this study include
Tidsram: 4 years
comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and evaluation of their prognostic value.
4 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Royal Marsden NHS Foundation Trust

Utredare

  • Studiestol: David Cunningham, The Royal Marsden Hospital NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 januari 2019

Primärt slutförande (Förväntat)

10 januari 2023

Avslutad studie (Förväntat)

10 januari 2023

Studieregistreringsdatum

Först inskickad

7 februari 2019

Först inskickad som uppfyllde QC-kriterierna

12 februari 2019

Första postat (Faktisk)

15 februari 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CCR4753

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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