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| Name | Class |
|---|---|
| Hopitaux Robert Schuman | UNKNOWN |
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The ColoPan study evaluates the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer and pancreatic ductal adenocarcinoma patients. It combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids.
The ColoPan study aims to evaluate the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) patients. The approach combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids (PDSOs). The study aims to generate robust evidence that could inform the design of future interventional trials and contribute to the broader goal of refining personalised oncology strategies. The current protocol focuses on the new enrolment of PDAC participants, while data generated from prospective enrolment or biospecimens collected under the ethically approved SOCS study will be used under a secondary use agreement. The study aims to assess the scientific validity and predictive performance of the PFP platform in precision oncology research for CRC and PDAC, determining whether drug sensitivity profiles correlate with actual patient outcomes. The study also explores the feasibility of implementing PFP workflows in research settings and their potential for future integration into clinical trial design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRC | Participants are included while scheduled for biopsy or surgery of their colorectal cancer. |
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| PDAC | Participants are included while scheduled for biopsy or surgery of their cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Functional Profiling | Other | This is an observational study where biological samples are collected to provide Personalized Functional Profiling, an integrated strategy that combines genomic analysis with direct drug response assessments using patient-derived spheroids/organoids (PDSOs) |
| Measure | Description | Time Frame |
|---|---|---|
| PFP platform's predictive performance | Degree of concordance between drug sensitivity profiles generated by the PFP platform and actual clinical responses observed in patients with CRC and PDAC treated with Standard of Care therapies. | 0-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the exploratory value of PFP-derived functional profiles | Correlation between the ex vivo drug sensitivity data and observed clinical outcomes | 0-5 years |
| Feasibility and Operational Evaluation of the PFP Platform |
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Inclusion Criteria:
Exclusion Criteria:
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This study targets patients undergoing surgery or biopsy at Hôpital Robert Schuman (HRS) in Luxembourg.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Jun Kwon, phD | Contact | +352 26970-288 | yong-jun.kwon@lih.lu |
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The participant will be proposed to signed a secondary use notice. For the participants who agreed, samples and data will be open for sharing to other researchers in collaboration.
Data will be made available for collaboration after publication
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Blood and tissues are collected at incluision and in case of additional surgeries
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Take-on rate of patient samples-defined as the percentage of collected samples that successfully led to PDSO generation and subsequent drug screening.
| 0-5 years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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