Clinical trial · Observational
New bioMarkers tO straTIfy cOlorectal caNcer Referrals
Plasma Biomarkers in Stratifying Patients Referred Via the Lower Gastro-intestinal (LGI) Suspected Cancer Two-week Wait (2WW) Pathway
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate if a blood test for circulating progastrin (hPG80) and transposable elements (TEs) can accurately predict colorectal cancer (CRC) or polyps in adult patients referred to the 2-week wait (2WW) or Straight to Test (STT) pathways for suspected lower gastrointestinal cancer. The main questions it aims to answer are: Can plasma hPG80 levels accurately predict a diagnosis of CRC or polyps in patients undergoing standard 2WW investigations? Can transposable elements (TEs) in the plasma serve as predictive biomarkers for CRC diagnosis in these patients? What are the patient preferences for different diagnostic tests for CRC, particularly a blood-based test compared to more invasive methods? Participants will: Provide a 20ml blood sample during a routine hospital visit for their 2WW diagnostic test (e.g., colonoscopy, CT Colon). Undergo standard clinical investigations as determined by their treating clinicians. Have their final diagnosis (cancer, polyp, or normal) correlated with their plasma hPG80 levels. For a subset of 100 participants (25 with confirmed CRC, 75 non-cancer), have their plasma analyzed for circulating signatures using RNAseq and DNAseq. Complete an electronic post-study questionnaire to explore their preferences and experiences with different CRC diagnostic tests used within the 2WW pathway.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Polyp | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with flag symptoms referred via 2 week wait pathway to exclude colorectal cancer.
- description
- An additional blood sample for the study.
Primary outcomes (2)
- measure
- Predictive value of hPG80 to identify colorectal cancer and adenomatous polyp
- timeFrame
- From enrollment to 8 weeks (or until the 2WW diagnostic test is completed and the outcome available).
- description
- Sensitivity and Specificity of hPG80 to determine colorectal cancer and adenomatous polyp
- measure
- Identification of Transposable Element (TE) signatures in plasma of colorectal cancer patients
- timeFrame
- From enrollment to 8 weeks (or until the 2WW diagnostic test is completed and the outcome available).
- description
- Expression of transposable element (TE) signatures in the plasma of patients with colorectal cancer and adenomatous polyps compared to healthy controls.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult, lower GI 2WW and or Straight to Test (STT) referral patients with suspected lower GI cancer. * Male and Female patients aged \>18 years. * 2WW referral patients with no history of inflammatory bowel disease. * Performance status (ECOG 0-2; and 3 pending clinical assessment of fitness). * Patients with capacity to consent to the study. Exclusion Criteria: * Any patients referred outside of the 2WW and or STT referral pathways with suspected Lower GI cancer or those referred as an emergency with or suspected CRC. * Age \< 18 years. * Patients not fit for standard investigations (e.g. not fit for gastroscopy, colonoscopy or CT colonography) in the 2WW pathway. * Patients with no capacity to consent or who declined consent for participation. * Patients with untreated solid organ cancers. * Patients with known inflammatory bowel disease. * Patients with documented familial type CRC.
References
Publications (5)
- BACKGROUNDReggiardo RE, Maroli SV, Peddu V, Davidson AE, Hill A, LaMontagne E, Aaraj YA, Jain M, Chan SY, Kim DH. Profiling of repetitive RNA sequences in the blood plasma of patients with cancer. Nat Biomed Eng. 2023 Dec;7(12):1627-1635. doi: 10.1038/s41551-023-01081-7. Epub 2023 Aug 31. PMID 37652985
- BACKGROUNDAlix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021 Apr;11(4):858-873. doi: 10.1158/2159-8290.CD-20-1311. PMID 33811121
- BACKGROUNDLykoskoufis NMR, Planet E, Ongen H, Trono D, Dermitzakis ET. Transposable elements mediate genetic effects altering the expression of nearby genes in colorectal cancer. Nat Commun. 2024 Jan 25;15(1):749. doi: 10.1038/s41467-023-42405-0. PMID 38272908
- BACKGROUNDPrieur A, Cappellini M, Habif G, Lefranc MP, Mazard T, Morency E, Pascussi JM, Flaceliere M, Cahuzac N, Vire B, Dubuc B, Durochat A, Liaud P, Ollier J, Pfeiffer C, Poupeau S, Saywell V, Planque C, Assenat E, Bibeau F, Bourgaux JF, Pujol P, Sezeur A, Ychou M, Joubert D. Targeting the Wnt Pathway and Cancer Stem Cells with Anti-progastrin Humanized Antibodies as a Potential Treatment for K-RAS-Mutated Colorectal Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5267-5280. doi: 10.1158/1078-0432.CCR-17-0533. Epub 2017 Jun 9. PMID 28600477
- BACKGROUNDYou B, Mercier F, Assenat E, Langlois-Jacques C, Glehen O, Soule J, Payen L, Kepenekian V, Dupuy M, Belouin F, Morency E, Saywell V, Flaceliere M, Elies P, Liaud P, Mazard T, Maucort-Boulch D, Tan W, Vire B, Villeneuve L, Ychou M, Kohli M, Joubert D, Prieur A. The oncogenic and druggable hPG80 (Progastrin) is overexpressed in multiple cancers and detected in the blood of patients. EBioMedicine. 2020 Jan;51:102574. doi: 10.1016/j.ebiom.2019.11.035. Epub 2019 Dec 24. PMID 31877416