Serum Talin-1 and Cripto-1 in Colorectal Cancer (Talin-1/CR-1)

February 12, 2026 updated by: Shrook S. Ahmed, Assiut University

Evaluating Serum Talin-1 and Cripto-1 as Diagnostic Biomarkers in Colorectal Cancer

The goals of this study are

  • To evaluate the clinical utility of Talin-1 and Cripto-1 measurement in colorectal cancer patients in comparison with healthy controls.
  • To Compare the diagnostic significance of serum Talin-1 and Cripto-1 with traditional serum biomarker CEA

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Colorectal cancer (CRC) is a major global health concern, ranking as the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths. CRC is a malignancy predominantly affecting older adults, posing significant threats to their health and creating formidable challenges for healthcare systems.

Compared to younger patients, elderly CRC often presents with atypical symptoms. In some cases, the initial manifestations are not hematochezia or abdominal pain but anaemia and weight loss, leading to frequent late-stage (Stage IV) diagnoses, which complicates treatment.

Talin-1 serves as a crucial element within the multiprotein adhesion complexes that facilitate processes such as cell migration, adhesion, and integrin signalling. It has been demonstrated that the level of Talin-1 in the serum of colon cancer patients was significantly higher than that of healthy controls. Talin-1 may be a valuable biomarker for colon cancer, which may be essential for the early detection, especially in combination with other markers in population screenings that are currently used to detect the colon cancer.

Human Cripto-1 (CR-1) is an embryonic gene, belonging to the EGF-CFC gene family, which is necessary for promoting early stages of embryonic development. CR-1 is a good example of a multifaceted embryonic protein that is re-expressed in most human tumors, particularly colorectal tumor, but not detected in normal adult human tissues. García-Sanmartín et al. showed that Cripto-1 expression was significantly correlated with worse prognosis in CRC, and was an independent prognostic factor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sherouk Ahmed Sayed, Assistant lecturer
  • Phone Number: +201009922949 +201123232632
  • Email: shrookabozaid@gmail.com

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 17777
        • Assuit University Hospital
        • Contact:
          • Sherouk Ahmed
          • Phone Number: 01123232632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age >18 years Old.
  • Patients of both sexes who met the clinical diagnostic criteria of colorectal cancer (change in bowel habit, absolute or recurrent constipation, rectal bleeding, significant weight loss or intestinal obstruction)
  • Patients diagnosed with colorectal cancer by imaging and histopathology

Exclusion Criteria:

  • Age <18 years old.
  • Patients with past history of chemotherapy or surgical excision of tumor
  • Patients with familial adenomatous polyposis
  • Patients with hereditary non-polyposis colorectal cancer
  • Patients with inflammatory bowel disease
  • patients with other types of tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group(1)
Diagnostic test: Serum level of Human Talin-1
To evaluate the clinical utility of Talin-1 measurement in colorectal cancer patients in comparison with healthy controls.
Diagnostic test: Serum level of Human Cripto-1
To evaluate the clinical utility of Cripto-1 measurement in colorectal cancer patients in comparison with healthy controls.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum Talin-1 measurement in colorectal cancer patients
Time Frame: From enrollment up to one week
measuring serum level of talin-1 in colorectal cancer patient to compare its level with healthy control
From enrollment up to one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum Cripto-1 measurement in colorectal cancer patients
Time Frame: From enrollment up to one week
From enrollment up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHROOK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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