Colorectal CarcinomaNCT06978595
Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies
An observational study of Colorectal Carcinoma and Cancer, run by asmaa salama ibrahim at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Carcinoma, Cancer, Signet Ring Adenocarcinoma of the Colon
- How many people
- 8,171 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2000to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Patients diagnosed with primary colorectal SRCC between 2000 and 2021
- Latency exclusion period of two months
Who cannot join
- patients with unknown age data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies: a Retrospective Cohort Based on SEER Database From 2000-2021
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.
- Keywords
- signet ring carcinoma, SEER, Cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Carcinoma, Signet Ring Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The excess risk per 10,000 was calculated using SEER*stat software.
Measured: from Jan, 2000 till Dec, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2000
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- asmaa salama ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, asmaa salama ibrahim, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978595
- Sponsor's protocol ID
- Z2730
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies: a Retrospective Cohort Based on SEER Database From 2000-2021
- ClinicalTrials.gov ID
- NCT06978595
- Acronym / sponsor ID
- Z2730
- Keywords
- signet ring carcinoma, SEER, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,171 participants (actual)
- Lead sponsor
- asmaa salama ibrahimUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Patients diagnosed with primary colorectal SRCC between 2000 and 2021
- Latency exclusion period of two months
Key exclusion criteria (1 listed)
- patients with unknown age data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The standardized incidence ratio of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma
Time frame: from Jan, 2000 till Dec, 2021
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).
1 secondary outcome
The excess risk of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma
Time frame: from Jan, 2000 till Dec, 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma and Cancer, run by asmaa salama ibrahim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The standardized incidence ratio of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma (time frame: from Jan, 2000 till Dec, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.