Clinical trial · Observational
Evaluation of Somatic Mutation Spectrum as Biomarker for Survival Outcome in Chinese CRC
A Cohort Study Evaluating the Effectiveness of the Somatic Mutation Spectrum Model in CRC Prognosis and Prediction Stratification
NCT04228614CI-TRIAL-00042858unknownClinicalTrials.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)
By analyse the tissue/blood variant spectrum model using NGS, the present clinical trial aims to elucidate the genetic basis of CRC in Chinese; to establish of CRC genetic map in Chinese patients; to identification new genetic biomarkers, drug and pathways; and to subtyping for precision treatment and management for Chinese CRC patients.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- Whole exome sequencing of 2500 retrospective tissue sample.
- label
- Prospective cohort
- description
- Whole exome sequencing of 500 prospectively collected tissue samples. Panel sequencing of 451 genes of prospectively collected blood samples.
Primary outcomes (2)
- measure
- prediction accuracy of survival rate
- timeFrame
- through study completion, an average of 5 years
- description
- We will use the gene mutation data and follow-up data of the patients to construct a prediction model,the accuracy of model to anticipating the 5 year survival rate of patients is the primary endpoint
- measure
- prediction accuracy of recurrent rate
- timeFrame
- through study completion, an average of 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Retrospective cohort: 1. The patient had no previous history of tumor prior to the diagnosis of colorectal cancer. 2. The tissue samples of patients were obtained from the radical(stage I-III) or palliative (stage IV) resection of colorectal cancer. 3. The clinical data of patients are complete. 4. The treatment record of the patients after surgery are complete, and the fellow-up data are available. Prospective cohort: 1. Patients who were diagnosed as stage IV colorectal cancer and planed to received palliative systematic chemotherapy. 2. Paired 10 ml blood and tissue samples should be available 3. The clinical informations of patients and definite pathological diagnosis of colorectal cancer should be obtained 4. Patients agree with the group to follow-up them and provide follow-up informations 5. Performance status ECOG（Eastern Cooperative Oncology Group） score ≤2 6. Informed consent must be obtained from the patient Exclusion Criteria: Retrospective cohort: 1. The patient had previous history of tumor prior to colorectal cancer surgery 2. The clinical data of patients are not available 4\. The date of treatment after surgery are not integrity, outcome data are not available Prospective cohort: 1. The patient received a blood transfusion within three months; 2. The patient has active HIV, hepatitis B or hepatitis C infection; 3. pregnant patients; 4. Alcohol or drug users; 5. Other situation that researchers considered might affect the results of the experiment or violate the ethics.
References
Publications (6)
- BACKGROUNDGuinney J, Dienstmann R, Wang X, de Reynies A, Schlicker A, Soneson C, Marisa L, Roepman P, Nyamundanda G, Angelino P, Bot BM, Morris JS, Simon IM, Gerster S, Fessler E, De Sousa E Melo F, Missiaglia E, Ramay H, Barras D, Homicsko K, Maru D, Manyam GC, Broom B, Boige V, Perez-Villamil B, Laderas T, Salazar R, Gray JW, Hanahan D, Tabernero J, Bernards R, Friend SH, Laurent-Puig P, Medema JP, Sadanandam A, Wessels L, Delorenzi M, Kopetz S, Vermeulen L, Tejpar S. The consensus molecular subtypes of colorectal cancer. Nat Med. 2015 Nov;21(11):1350-6. doi: 10.1038/nm.3967. Epub 2015 Oct 12. PMID 26457759
- BACKGROUNDRolfo C, Castiglia M, Hong D, Alessandro R, Mertens I, Baggerman G, Zwaenepoel K, Gil-Bazo I, Passiglia F, Carreca AP, Taverna S, Vento R, Santini D, Peeters M, Russo A, Pauwels P. Liquid biopsies in lung cancer: the new ambrosia of researchers. Biochim Biophys Acta. 2014 Dec;1846(2):539-46. doi: 10.1016/j.bbcan.2014.10.001. Epub 2014 Oct 16. PMID 25444714
- BACKGROUNDYu SC, Lee SW, Jiang P, Leung TY, Chan KC, Chiu RW, Lo YM. High-resolution profiling of fetal DNA clearance from maternal plasma by massively parallel sequencing. Clin Chem. 2013 Aug;59(8):1228-37. doi: 10.1373/clinchem.2013.203679. Epub 2013 Apr 19. PMID 23603797
- BACKGROUNDNewman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6. PMID 24705333
- BACKGROUNDGarcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021. PMID 26311728
- BACKGROUNDTie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.