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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. februar 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Rekruttering
        • The Royal Marsden NHS Foundation Trust
        • Kontakt:
        • Underforsker:
          • David Lau

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 years
comparison of biomarker expression among IPMN, MCN, and pancreatic adenocarcinoma and evaluation of their prognostic value.
4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Royal Marsden NHS Foundation Trust

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2019

Primær færdiggørelse (Forventet)

10. januar 2023

Studieafslutning (Forventet)

10. januar 2023

Datoer for studieregistrering

Først indsendt

7. februar 2019

Først indsendt, der opfyldte QC-kriterier

12. februar 2019

Først opslået (Faktiske)

15. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCR4753

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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