Evaluation of Somatic Mutation Spectrum as Biomarker for Survival Outcome in Chinese CRC

NCT04228614 | Unknown

• 1 other identifier: mutation spectrum model-CRC
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• prediction accuracy of survival rate

  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

  through study completion, an average of 5 years

• prediction accuracy of recurrent rate

  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 3 year recurrent rate of patients is the primary endpoint

  through study completion, an average of 3 years

Secondary Outcomes (1)

• Mutation Consistency of tissue and blood sample

  through study completion, an average of 3 years

Study Arms (2)

Retrospective cohort

Whole exome sequencing of 2500 retrospective tissue sample.

Prospective cohort

Whole exome sequencing of 500 prospectively collected tissue samples. Panel sequencing of 451 genes of prospectively collected blood samples.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient of the prospective cohort should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent of the prospective cohort should be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

You may qualify if:

• Retrospective cohort:
• The patient had no previous history of tumor prior to the diagnosis of colorectal cancer.
• The tissue samples of patients were obtained from the radical(stage I-III) or palliative (stage IV) resection of colorectal cancer.
• The clinical data of patients are complete.
• The treatment record of the patients after surgery are complete, and the fellow-up data are available.
• Prospective cohort:
• Patients who were diagnosed as stage IV colorectal cancer and planed to received palliative systematic chemotherapy.
• Paired 10 ml blood and tissue samples should be available
• The clinical informations of patients and definite pathological diagnosis of colorectal cancer should be obtained
• Patients agree with the group to follow-up them and provide follow-up informations
• Performance status ECOG（Eastern Cooperative Oncology Group） score ≤2
• Informed consent must be obtained from the patient

You may not qualify if:

• Retrospective cohort:
• The patient had previous history of tumor prior to colorectal cancer surgery
• The clinical data of patients are not available
• \. The date of treatment after surgery are not integrity, outcome data are not available
• Prospective cohort:
• The patient received a blood transfusion within three months;
• The patient has active HIV, hepatitis B or hepatitis C infection;
• pregnant patients;
• Alcohol or drug users;
• Other situation that researchers considered might affect the results of the experiment or violate the ethics.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

• Guinney 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 BACKGROUND

• Rolfo 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 BACKGROUND

• Yu 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 BACKGROUND

• Newman 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 BACKGROUND

• Garcia-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 BACKGROUND

• Tie 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.

  PMID: 27384348 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The fresh tumor tissues/biopsies of each patient will be collected during the surgical resection. The peripheral blood samples of each patient will be collected at the following time points: 1) prior to the surgical treatment; 2) prior to the chemotherapy/targeted therapy/immunotherapy; 3) every real efficacy evaluation, until disease progression (up to 24 months).

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ruihua Xu, MD.,PhD

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang, MD.,PhD.

CONTACT

+862087343795; wangfeng@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: January 14, 2020
• Study Start: May 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

CN (1)