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Trial record 4 of 5155 for:    colon cancer

The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

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ClinicalTrials.gov Identifier: NCT03794193
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
Beijing Cancer Hospital
West China Hospital
Ruijin Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Koo Foundation Sun Yat-Sen Cancer Center
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.

Condition or disease Intervention/treatment
Colon Cancer Procedure: Radical resection of colon cancer

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Study Type : Observational
Estimated Enrollment : 1318 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Intervention Details:
  • Procedure: Radical resection of colon cancer
    The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.
    Other Name: Chemotherapy


Primary Outcome Measures :
  1. 3-year Disease-free Survival [ Time Frame: Within 3 years after surgery ]
    The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.


Secondary Outcome Measures :
  1. 3-year Over-all Survival [ Time Frame: Within 3 years after surgery ]
    The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.

  2. Postoperative complication rate [ Time Frame: Within 30 days after surgery ]
  3. Postoperative mortality rate [ Time Frame: Within 30 days after surgery ]
  4. Local recurrence rate [ Time Frame: Within 3 years after surgery ]
  5. Distant organ metastasis rate [ Time Frame: Within 3 years after surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colon cancer patients with or without unfavorable histological features
Criteria

Inclusion Criteria:

  1. Age: 18-80 years old;
  2. Postoperative pathology confirmed colon adenocarcinoma;
  3. The tumor is located from the cecum to the sigmoid colon;
  4. No distant organ metastasis;
  5. ASA score I-III.

Exclusion Criteria:

  1. Simultaneous or metachronous multiple primary colorectal cancer;
  2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
  3. local excision procedure;
  4. palliative resection (R2 resection);
  5. pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794193


Contacts
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Contact: Yi Xiao, MD +86 10 69152212 xiaoy@pumch.cn
Contact: Jun-Yang Lu, MD +86 10 69152217 lujunyang@pumch.cn

Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Cancer Hospital
West China Hospital
Ruijin Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Koo Foundation Sun Yat-Sen Cancer Center
Investigators
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Principal Investigator: Yi Xiao, MD Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03794193     History of Changes
Other Study ID Numbers: ZS-1653
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data can be shared with all researchers involved in the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases