Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies

NCT06978595 | Completed

• 1 other identifier: Z2730
• Study Type: observational
• Target: 8,171
• Locations: 1 country
• Sites: 1

Brief Summary

This original research investigates the critical issue of gastrointestinal (GI) second primary malignancies (SPMs) in patients with signet ring cell carcinoma (SRCC), a rare and aggressive subtype of colorectal cancer. Utilizing the Surveillance, Epidemiology, and End Results (SEER) database, the investigators assessed the risk of GI SPMs, particularly within 2-11 months post-SRCC diagnosis.

Conditions

Colorectal Carcinoma; Cancer; Signet Ring Adenocarcinoma of the Colon

Keywords

signet ring carcinoma; SEER; Cancer

Outcome Measures

Primary Outcomes (1)

• The standardized incidence ratio of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma

  The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) for second primary gastrointestinal malignancies. Patients diagnosed with primary colorectal SRCC between 2000 and 2021 were included. The event was defined as the appearance of an SPM in a different site from the original cancer at a new GI organ (esophagus, stomach, small intestine, cecum, appendix, rectum, anus and anal canal, liver, gallbladder, intrahepatic bile duct, pancreas, retro-peritoneum, and colon).

  from Jan, 2000 till Dec, 2021

Secondary Outcomes (1)

• The excess risk of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma

  from Jan, 2000 till Dec, 2021

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with primary colorectal SRCC between 2000 and 2021 were included. Demographic characteristics extracted included race (White, Black, and other races: American Indian/Alaska Native and Asian/Pacific Islander), age (pediatrics: \<18 years, young adults: 18-39 years, middle-aged: 40-64 years, elderly: ≥65 years, according to the WHO classification), marital status (married, unmarried, or unknown), and year of diagnosis. Tumor-related variables included stage (in situ, localized, regional, distant, per SEER staging definitions \[19\]), tumor grade (well-differentiated/grade I, moderately differentiated/grade II, poorly differentiated/grade III, undifferentiated anaplastic/grade IV, and unknown grade), and treatment-related variables (chemotherapy, radiation, and surgery).

You may qualify if:

• Patients diagnosed with primary colorectal SRCC between 2000 and 2021

You may not qualify if:

• patients with unknown age data

Sponsors & Collaborators

• asmaa salama ibrahim: lead

Study Sites (1)

Suez Canal University

Ismailia, 41512, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Carcinoma, Signet Ring Cell

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident physician of gastroenterology

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: January 1, 2000
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

EG (1)