NCT06096493

Brief Summary

Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 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

May 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 19, 2023

Last Update Submit

October 21, 2023

Conditions

Rectal Cancer

Keywords

cancer rectumrecurrencedisease free survival

Outcome Measures

Primary Outcomes (2)

  • Tumor recurrence

    Presence of Tumor recurrence after curative surgery for cancer rectum.

    Through study completion, an average of 3 year

  • Disease free survival.

    From date of surgery until the date of recurrence detection.

    up to 5 years

Study Arms (1)

Patients with cancer rectum underwent curative surgery

Patients with cancer rectum underwent curative surgery

Procedure: curative surgery for cancer rectum

Interventions

curative surgery for cancer rectumPROCEDURE

Curative surgery for cancer rectum.

Patients with cancer rectum underwent curative surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Patients who had curative surgery for cancer rectum.

You may qualify if:

  • Patients who had curative surgery for cancer rectum.

You may not qualify if:

  • Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months
  • Patients that lost follow-up will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

RECRUITING

Related Publications (6)

  • He WZ, Xie QK, Hu WM, Kong PF, Yang L, Yang YZ, Jiang C, Yin CX, Qiu HJ, Zhang HZ, Zhang B, Xia LP. An increased number of negative lymph nodes is associated with a higher immune response and longer survival in colon cancer patients. Cancer Manag Res. 2018 Jun 18;10:1597-1604. doi: 10.2147/CMAR.S160100. eCollection 2018.

    PMID: 29950897BACKGROUND

  • 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

  • Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.

    PMID: 31203527BACKGROUND

  • Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.

    PMID: 6751457BACKGROUND

  • Tschmelitsch J, Kronberger P, Glaser K, Klingler A, Bodner E. Survival after surgical treatment of recurrent carcinoma of the rectum. J Am Coll Surg. 1994 Jul;179(1):54-8.

    PMID: 8019725BACKGROUND

  • Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850.

    PMID: 31543678BACKGROUND

MeSH Terms

Conditions

Rectal NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdallah M Taha, MD

    South Valley University, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah M Taha, MD

CONTACT

+201011716497abdallahsurgery@med.svu.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of general Surgery

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 23, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)