Clinical trial · Observational
Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes
NCT02198092CI-TRIAL-00040304Septin9completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.
Conditions
Conditions (5)
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
| Hnpcc | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| Map Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epi proColon Testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Patient Group FAP
- description
- Clinical diagnosis of familial adenomatous polyposis (FAP). The patients of the disease and control groups participating in the study are followed up clinically and with blood draws at least every 6 months for the duration of 2 years. These follow-ups might be more frequent, if warranted by the clinical course of the individual disease in the participating patients. Blood draws in FAP patients should always be accompanied by blood draws in their family member controls. If colectomy is performed in a patient of any disease group within the study participation period, additional blood draws will occur prior to any surgical bowel preparation and within a 28-day window after surgery.
- interventionNames
- Other: Epi proColon Testing
- label
- Patient Group Lynch Syndrome
- description
- Clinical diagnosis of Lynch Syndrome, also known as HNPCC. The patients of the disease and control groups participating in the study are followed up clinically and with blood draws at least every 6 months for the duration of 2 years. These follow-ups might be more frequent, if warranted by the clinical course of the individual disease in the participating patients. If colectomy is performed in a patient of any disease group within the study participation period, additional blood draws will occur prior to any surgical bowel preparation and within a 28-day window after surgery.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent provided * Age \> or = to 18 years of age * Patient group FAP \- Clinical diagnosis of familial adenomatous polyposis * Patient group Lynch syndrome Clinical diagnosis of Lynch syndrome * Patient group MAP \- Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps * Control group (FAP) \- Genetically related family member of patient * Patients: Able and willing to attend routine follow-up as advised * Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative Exclusion Criteria: * Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) * Current diagnosis of colorectal cancer * Pregnancy
References
Publications (3)
- BACKGROUNDRustgi AK. The genetics of hereditary colon cancer. Genes Dev. 2007 Oct 15;21(20):2525-38. doi: 10.1101/gad.1593107. PMID 17938238
- BACKGROUNDGaliatsatos P, Foulkes WD. Familial adenomatous polyposis. Am J Gastroenterol. 2006 Feb;101(2):385-98. doi: 10.1111/j.1572-0241.2006.00375.x. PMID 16454848
- BACKGROUNDLofton-Day C, Model F, Devos T, Tetzner R, Distler J, Schuster M, Song X, Lesche R, Liebenberg V, Ebert M, Molnar B, Grutzmann R, Pilarsky C, Sledziewski A. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008 Feb;54(2):414-23. doi: 10.1373/clinchem.2007.095992. Epub 2007 Dec 18. PMID 18089654