NCT03312374

Brief Summary

By monitoring the serum ctDNA mutational profile using NGS, the present clinical trial aims to elucidate the correlation between the postoperative ctDNA status and the prognosis of patients with early and intermediate-stage colorectal cancer, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

October 12, 2017

Last Update Submit

February 25, 2019

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival

    The primary endpoint for this study is Disease Free Survival (DFS), which will be assessed using RECIST version 1.1.

    through study completion, an average of 2 years

Study Arms (2)

stage II CRC

Patients with stage II colorectal cancer

stage III CRC

Patients with stage III colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must 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:

  • Male or female ≥ 18 years of age on the day of signing informed consent.
  • Patients must have histologically confirmed stage II/IIIcolorectal cancer.
  • Patients need to receive surgical resection.
  • Patients must have a performance status of ≤1 on the ECOG Performance Scale.
  • Patients must have survival of \> 12 months after the index date
  • Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

You may not qualify if:

  • Patients received adjuvant treatment prior to the surgical resection.
  • Patients received blood transfusion two weeks before or during the surgical resection.
  • Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
  • Patients who are pregnant.
  • Patients who are alcoholic or drug abusers.
  • Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 26457759RESULT

  • 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: 25444714RESULT

  • 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: 23603797RESULT

  • 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: 24705333RESULT

  • 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: 26311728RESULT

  • 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: 27384348RESULT

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) 3-7 days after the surgical resection; 3) every three months(starting from 6 months) until disease progression (up to 24 months).

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ruihua Xu, MD.,PhD.

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Feng Wang, MD.,PhD.

CONTACT

+862087343795wangfeng@sysucc.org.cn

Gong Chen, MD.

CONTACT

+862013500030531

Study Design

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

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2019

Study Completion

March 30, 2020

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

CN(1)