Maspin in Colorectal CarcinomaNCT06915350
The Role of Maspin in Colorectal Carcinoma, an Immunohistochemical Study
An observational study of Maspin in Colorectal Carcinoma, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Maspin in Colorectal Carcinoma
- What is being tested?
- maspin ( mammary serine protease inhibitor)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cases with different stages of colorectal adenocarcinoma with available paraffin blocks and clinical data
Who may be able to join
- all patients with different stages of colorectal carcinoma with available paraffin blocks and clinical data .
Who cannot join
- all cases not fulfill the inclusion criteria .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Maspin in Colorectal Carcinoma
- Being tested
- maspin ( mammary serine protease inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maspin ( mammary serine protease inhibitor)Other
Maspin is an immunohistochemical marker to detect the prognosis of colorectal carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
In our study we will assess the subcellular ( cytoplasmic or nuclear)expression of maspin in colorectal adenocarcinoma cases and correlate it with the prognosis
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Maspin in Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Salama Salah, Assiut University
- Investigators
- Asmaa Mahmoud, Assistant professor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915350
- Sponsor's protocol ID
- Maspin in colorectal carcinoma
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menbari Oskouie I, Alemi H, Khavandgar N, Mardani-Fard HA, AleTaha A, Mousavian AH, Rahimi A, Abdollahi M, Soltani A, Kasaeian A, Sorouri M. Global Research Trends on Colorectal Cancer (2014-2023): A Scientometric and Visualized Study. Arch Iran Med. 2024 Oct 1;27(10):563-572. doi: 10.34172/aim.31944. Epub 2024 Oct 1.
PubMed 39492563Smulders-Srinivasan TK, Jenkinson SE, Brown LJ, Lenis VP, Bass R. PDIA6 and Maspin in Prostate Cancer. Anticancer Res. 2023 Dec;43(12):5331-5340. doi: 10.21873/anticanres.16736.
PubMed 38030170Shankar E, Pandey M, Verma S, Abbas A, Candamo M, Kanwal R, Shukla S, MacLennan GT, Gupta S. Role of class I histone deacetylases in the regulation of maspin expression in prostate cancer. Mol Carcinog. 2020 Aug;59(8):955-966. doi: 10.1002/mc.23214. Epub 2020 May 11.
PubMed 32391971Elkady N, Elgendy W, Badr MT, Aiad H, Samara M, Badr NM. Evaluation of the diagnostic utility of NCOA3, Maspin and VHL protein expression in pancreatic ductal adenocarcinoma: An immunohistochemical study. Ann Diagn Pathol. 2024 Dec;73:152356. doi: 10.1016/j.anndiagpath.2024.152356. Epub 2024 Jun 18.
PubMed 38901088Tang S, Lian X, Jiang J, Cheng H, Guo J, Huang C, Meng H, Li X. Tumor Suppressive Maspin-Sensitized Prostate Cancer to Drug Treatment Through Negative Regulating Androgen Receptor Expression. Front Cell Dev Biol. 2020 Oct 26;8:573820. doi: 10.3389/fcell.2020.573820. eCollection 2020.
PubMed 33195208Sakabe T, Wakahara M, Shiota G, Umekita Y. Role of cytoplasmic localization of maspin in promoting cell invasion in breast cancer with aggressive phenotype. Sci Rep. 2021 May 31;11(1):11321. doi: 10.1038/s41598-021-90887-z.
PubMed 34059749Wang N, Chang LL. Maspin suppresses cell invasion and migration in gastric cancer through inhibiting EMT and angiogenesis via ITGB1/FAK pathway. Hum Cell. 2020 Jul;33(3):663-675. doi: 10.1007/s13577-020-00345-7. Epub 2020 May 14.
PubMed 32409959Shi S, Zhang ZG, Sang YZ, Sun J, Ma HY. A meta- and bioinformatics analysis of maspin expression levels influencing the prognosis of patients with breast cancer. Oncol Lett. 2024 Feb 23;27(4):173. doi: 10.3892/ol.2024.14306. eCollection 2024 Apr.
PubMed 38464336Baghel K, Kazmi HR, Chandra A, Raj S, Srivastava RN. Significance of methylation status of MASPIN gene and its protein expression in prognosis of gallbladder cancer. Asia Pac J Clin Oncol. 2019 Oct;15(5):e120-e125. doi: 10.1111/ajco.13129. Epub 2019 Feb 10.
PubMed 30740890Marioni G, Ottaviano G, Lovato A, Franz L, Bandolin L, Contro G, Giacomelli L, Alessandrini L, Stramare R, de Filippis C, Blandamura S. Expression of maspin tumor suppressor and mTOR in laryngeal carcinoma. Am J Otolaryngol. 2020 Jan-Feb;41(1):102322. doi: 10.1016/j.amjoto.2019.102322. Epub 2019 Oct 23.
PubMed 31732312
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Maspin (Mammary Serine Protease Inhibitor) in Colorectal Carcinoma, an Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT06915350
- Acronym / sponsor ID
- Maspin in colorectal carcinoma
- Conditions
- Maspin in Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Apr 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases with different stages of colorectal adenocarcinoma with available paraffin blocks and clinical data
Key inclusion criteria (1 listed)
- all patients with different stages of colorectal carcinoma with available paraffin blocks and clinical data .
Key exclusion criteria (1 listed)
- all cases not fulfill the inclusion criteria .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maspin ( mammary serine protease inhibitor)Maspin is an immunohistochemical marker to detect the prognosis of colorectal carcinoma | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 39492563Menbari Oskouie I, Alemi H, Khavandgar N, Mardani-Fard HA, AleTaha A, Mousavian AH, Rahimi A, Abdollahi M, Soltani A, Kasaeian A, Sorouri M. Global Research Trends on Colorectal Cancer (2014-2023): A Scientometric and Visualized Study. Arch Iran Med. 2024 Oct 1;27(10):563-572. doi: 10.34172/aim.31944. Epub 2024 Oct 1.
- Background: PubMed 38030170Smulders-Srinivasan TK, Jenkinson SE, Brown LJ, Lenis VP, Bass R. PDIA6 and Maspin in Prostate Cancer. Anticancer Res. 2023 Dec;43(12):5331-5340. doi: 10.21873/anticanres.16736.
- Background: PubMed 32391971Shankar E, Pandey M, Verma S, Abbas A, Candamo M, Kanwal R, Shukla S, MacLennan GT, Gupta S. Role of class I histone deacetylases in the regulation of maspin expression in prostate cancer. Mol Carcinog. 2020 Aug;59(8):955-966. doi: 10.1002/mc.23214. Epub 2020 May 11.
- Background: PubMed 38901088Elkady N, Elgendy W, Badr MT, Aiad H, Samara M, Badr NM. Evaluation of the diagnostic utility of NCOA3, Maspin and VHL protein expression in pancreatic ductal adenocarcinoma: An immunohistochemical study. Ann Diagn Pathol. 2024 Dec;73:152356. doi: 10.1016/j.anndiagpath.2024.152356. Epub 2024 Jun 18.
- Background: PubMed 33195208Tang S, Lian X, Jiang J, Cheng H, Guo J, Huang C, Meng H, Li X. Tumor Suppressive Maspin-Sensitized Prostate Cancer to Drug Treatment Through Negative Regulating Androgen Receptor Expression. Front Cell Dev Biol. 2020 Oct 26;8:573820. doi: 10.3389/fcell.2020.573820. eCollection 2020.
- Background: PubMed 34059749Sakabe T, Wakahara M, Shiota G, Umekita Y. Role of cytoplasmic localization of maspin in promoting cell invasion in breast cancer with aggressive phenotype. Sci Rep. 2021 May 31;11(1):11321. doi: 10.1038/s41598-021-90887-z.
- Background: PubMed 32409959Wang N, Chang LL. Maspin suppresses cell invasion and migration in gastric cancer through inhibiting EMT and angiogenesis via ITGB1/FAK pathway. Hum Cell. 2020 Jul;33(3):663-675. doi: 10.1007/s13577-020-00345-7. Epub 2020 May 14.
- Background: PubMed 38464336Shi S, Zhang ZG, Sang YZ, Sun J, Ma HY. A meta- and bioinformatics analysis of maspin expression levels influencing the prognosis of patients with breast cancer. Oncol Lett. 2024 Feb 23;27(4):173. doi: 10.3892/ol.2024.14306. eCollection 2024 Apr.
- Background: PubMed 30740890Baghel K, Kazmi HR, Chandra A, Raj S, Srivastava RN. Significance of methylation status of MASPIN gene and its protein expression in prognosis of gallbladder cancer. Asia Pac J Clin Oncol. 2019 Oct;15(5):e120-e125. doi: 10.1111/ajco.13129. Epub 2019 Feb 10.
- Background: PubMed 31732312Marioni G, Ottaviano G, Lovato A, Franz L, Bandolin L, Contro G, Giacomelli L, Alessandrini L, Stramare R, de Filippis C, Blandamura S. Expression of maspin tumor suppressor and mTOR in laryngeal carcinoma. Am J Otolaryngol. 2020 Jan-Feb;41(1):102322. doi: 10.1016/j.amjoto.2019.102322. Epub 2019 Oct 23.
- Individual participant dataSharing planned: No
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.
Asmaa Mahmoud, Assistant professor study director
Questions about this trial
What is this clinical trial studying?
An observational study of Maspin in Colorectal Carcinoma, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Salama, Demonstrator (01122643499, aya.salama@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06915350, which also lists 10 linked publications.
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 8 Apr 2025.