The Role of Maspin in Colorectal Carcinoma, an Immunohistochemical Study

April 3, 2025 updated by: Aya Salama Salah, Assiut University

The Role of Maspin (Mammary Serine Protease Inhibitor) in Colorectal Carcinoma, an Immunohistochemical Study

Colorectal carcinoma (CRC) is a common cancer that arises from genetic and epigenetic changes in colon stem cells. The protein maspin acts as a tumor suppressor, influencing cell adhesion, motility, apoptosis, and angiogenesis. Its role varies by localization within cells; cytoplasmic maspin is associated with low metastatic risk, while nuclear maspin is linked to early recurrence in advanced CRC. Maspin's function can be either tumor-suppressive or oncogenic, depending on its expression and methylation status. Further research is needed to fully understand its prognostic significance in CRC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Colorectal carcinoma (CRC) ranks as the third most common cancer worldwide, significantly contributing to cancer-related deaths and increasingly affecting younger populations .CRC develops when stem cells present at the base of the colon crypts undergo genetic and epigenetic modifications which affect oncogenes and tumour suppressor genes, leading to the transformation of normal stem cells to cancerous stem cells .Tumor suppressor genes( TSGs) : are genes involved in DNA damage repair, inhibition of cell division, induction of apoptosis, and suppression of metastasis . Maspin(mammary serine protease inhibitor) is a protease inhibitor of the serpin family, known to have tumor suppressor activity .maspin was called a multifaced protein, because it interacts with diverse groups of intercellular and extracellular proteins, and regulates cell adhesion, motility, apoptosis, and angiogenesis.Maspin expression has been demonstrated in multiple tissues including epithelium of the breast, prostate. Depending on the cell type, maspin also demonstrates a broad localization pattern. In mammary epithelial cells, maspin localizes primarily to the cytoplasm, but can also localize to the nucleus (in myoepithelial cells), secretory vesicles, and the cell surface. The localization of maspin appears important to its function(s) since in some tissues, aberrant maspin localization can be indicative of a neoplastic lesion. demonstrated that the cytoplasmic localization of maspin in ovarian carcinoma coincided with a poor prognosis, whereas nuclear maspin localization in these cancers was indicative of a more benign lesion, suggesting an important tumor-suppressive r role for nuclear maspin. Maspin has two opposing roles in cancer, it acts as a tumor suppressor that is down-regulated in gastric, breast versus an oncogenic role as it is over-expressed in gall bladder carcinoma.

Its role as tumor suppressor gene occurs through promoter hypomethylation and histone acetylation. On the contrary, maspin promoter methylation is associated with maspin tumor suppressor gene silencing and oncogenic potentiation. To our knowledge,few studies assesed the prognostic role of maspin in colorectal carinoma . Investigators reported that the prognostic role of maspin depend on it's subcellular localization as the cytoplasmic maspin positivity is considered as an indicator of low metastatic risk and late recurrence but nuclear positivity is correlated with early recurrence after surgery, especially for advanced stage carcinomas. study will include 50 formalin-fixed parrafin embedded blocks of Colorectal carcinoma cases . Colectomy specimens will be obtained from the archive of the Surgical Pathology Laboratory Assiut University Hospital, Faculty of Medicine. The cliniopathological features will be obtained from the hospital medical records, including patient age, gender, tumor site, tumor size . Representative hematoxylin and eosin-stained slides of tumor will be examined for each specimen for identification of the following features: histologic type and grade according to WHO( World Health Organization) classification of colon and rectal tumors, 5th edition, 2019) , lympho-vasular(LVI) and perineural invasion (PNI),depth of tumor invasion, lymph node metastasis, pathologic stage (according to TNM classification of the American Joint Committee on Cancer (AJCC) 8th edition. Immunohistochemical staining:Tissue sections of 4 µm thickness of formalin-fixed paraffin-embedded specimens will be taken from tissue blocks. Sections will be deparaffinized in xylene and rehydrated in a descending graded ethanol series. The endogenous peroxidase will be blocked with 6% hydrogen peroxide. For epitope retrieval, sections will be microwaved in citrate buffer, pH 6. Then sections will be incubated with the primary antibodies (Maspin) Then the Secondary staining kits were used according to the manufacturers instructions

Study Type

Observational

Enrollment (Estimated)

50

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 Backup

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All cases with different stages of colorectal adenocarcinoma with available paraffin blocks and clinical data

Description

Inclusion Criteria:

  • all patients with different stages of colorectal carcinoma with available paraffin blocks and clinical data .

Exclusion Criteria:

  • all cases not fulfill the inclusion criteria .

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In our study we will assess the subcellular ( cytoplasmic or nuclear)expression of maspin in colorectal adenocarcinoma cases and correlate it with the prognosis
Time Frame: Baseline
For the immunostains, the subcellular localization is indicated to be quantified based on the intensity, percentage and localization in the tumor cells Using a cut-off point, cases can be grouped in: negative cases, carcinomas with cytoplasm predominance (cytoplasmic high and nuclear low), nuclear expression (cytoplasmic low and nuclear high), respectively with mixed expression (dual positivity, with high cytoplasm and high nuclear intensity) and correlate this expressions with prognosis , cases with cytoplasmic predominance mean good prognosis , and cases with nuclear predominance mean poor prognosis
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Asmaa Mahmoud, Assistant professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maspin in colorectal carcinoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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