NCT05667259

Brief Summary

This study was conducted to compare the significance of lymph node ratio and absolute count of positive lymph node count on overall survival in patients with rectal cancer who underwent resection with curative intent

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

10 years

First QC Date

December 19, 2022

Last Update Submit

December 27, 2022

Conditions

Keywords

Cancer RectumLymph node ratioOverall SurvivalPrognosis

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Survival was calculated for each patient based on time of surgery to time of death.

    up to 10 years (From date of surgery to the date date of death)

Interventions

Curative resection for cancer recum

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with rectal cancer that were admitted in tertiary hospitals and underwent curative rectal resection. Patients' files were reviewed, and the data were collected and tabulated.

You may qualify if:

  • Patient with rectal cancer of stage I-III.
  • patients underwent radical resection with curative intent.

You may not qualify if:

  • Patients with Familial Adenomatous Polyposis, multiple synchronous or metachronous rectal cancers.
  • Early post-operative recurrence, or death within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

Location

Related Publications (5)

  • Li Destri G, Di Carlo I, Scilletta R, Scilletta B, Puleo S. Colorectal cancer and lymph nodes: the obsession with the number 12. World J Gastroenterol. 2014 Feb 28;20(8):1951-60. doi: 10.3748/wjg.v20.i8.1951.

    PMID: 24587671BACKGROUND
  • Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.

    PMID: 28094848BACKGROUND
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND
  • Le Voyer TE, Sigurdson ER, Hanlon AL, Mayer RJ, Macdonald JS, Catalano PJ, Haller DG. Colon cancer survival is associated with increasing number of lymph nodes analyzed: a secondary survey of intergroup trial INT-0089. J Clin Oncol. 2003 Aug 1;21(15):2912-9. doi: 10.1200/JCO.2003.05.062.

    PMID: 12885809BACKGROUND
  • Tepper JE, O'Connell MJ, Niedzwiecki D, Hollis D, Compton C, Benson AB 3rd, Cummings B, Gunderson L, Macdonald JS, Mayer RJ. Impact of number of nodes retrieved on outcome in patients with rectal cancer. J Clin Oncol. 2001 Jan 1;19(1):157-63. doi: 10.1200/JCO.2001.19.1.157.

    PMID: 11134208BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Abdallah M Taha, MD

    Egypt, South Valley University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of General Surgry

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 28, 2022

Study Start

January 1, 2012

Primary Completion

January 1, 2022

Study Completion

December 1, 2022

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations