Colorectal AdenocarcinomaNCT07003776
Evaluation of Tumor Budding In Colorectal Adenocarcinoma
An observational study of Colorectal Adenocarcinoma, run by Sohag University.
Trial summary
Colorectal cancer (CRC) is among the most prevalent cancers globally, with approximately one to two million new cases diagnosed each year. This makes CRC the third most common cancer and the fourth leading cause of cancer-related deaths, with 700,000 deaths per year, exceeded only by lung, liver and stomach cancers. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Biological: Immunohistochemical staining
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 3 May 2026
- 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 20 to 90 years
- All sexes
- Adult, Older adult
Study population: Archived Formalin-fixed, Paraffin-embedded tissue blocks belonged to patients suffered from colonic and/or rectal cancers. Patients were admitted to sohag university hospital and underwent colectomy and their colonic specimens were sent to Pathology Laboratory of the same hospital to ascertain diagnosis and tumor phenotype.
Who may be able to join
- Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.
Who cannot join
- Tissue blocks with insufficient, destroyed or necrotic material. Specimens with insufficient clinical data.
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
Colorectal cancer (CRC) is among the most prevalent cancers globally, with approximately one to two million new cases diagnosed each year. This makes CRC the third most common cancer and the fourth leading cause of cancer-related deaths, with 700,000 deaths per year, exceeded only by lung, liver and stomach cancers. CRC accounts for about 10% of all cancer diagnoses worldwide (Sung et al., 2021; Masetti et al., 2022) .
CRC affects different races and ethnicities at various age groups in distinct ways. Among patients younger than 50 years old, the proportion of CRC is nearly double for Black individuals (16%) compared to White individuals (9%) and Hispanic individuals (6%). In Egypt, CRC ranked the seventh among cancers, following lung, breast, prostate, liver, and bladder cancers (Mounir et al., 2022).
Read more
Tumor budding (TB) is characterized by the presence of individual tumor cells or small clusters of up to four cells at the invasive margin of a tumor. This histological feature, which indicates the separation of malignant cells from the main tumor mass, has intrigued pathologists since it was first identified in the 1950s (Giordano et al., 2024).
Evaluating TB is crucial for improving prognostic accuracy and informing treatment decisions. Tumors with high-grade TB exhibit a significantly lower 5-year Disease-Free Survival (DFS) rate compared to those with low-grade TB. High-grade TB is regarded as a negative prognostic factor and is associated with an increased risk of recurrence (Kyong Shin et al., 2023).
TB can be observed in conventional slides when prominent, but careful observation is necessary. A more thorough assessment of TB is more easily achieved if the neoplastic epithelium is highlighted using pan-cytokeratin immunostains (Mishra et al., 2022).
Pan-keratin (Pan-CK) antibodies are proteins derived from cytoskeletal intermediate filaments. These antibodies are a mixture designed to detect multiple low and high molecular weight keratins. Their primary purpose is to allow for the immunohistochemical identification of all epithelial cell types, regardless of their tissue of origin, using a single diagnostic tool.
In surgical pathology, Pan-CK antibodies are commonly used to confirm the epithelial origin of both neoplastic (tumorous) and non-neoplastic tissues, as well as to identify small metastases in lymph nodes. However, there are limitations to the assumption that Pan-CK antibodies will stain all epithelial tumors and that non-epithelial tissues will be "keratin negative." It has been reported that a diverse range of epithelial tumors can be Pan-CK negative, challenging the notion that these antibodies are universally applicable (Wick et al., 1986; Badzio, 2019).
Pan-CK can help diagnose disease like breast cancer, lung cancer, prostate cancer, and colorectal cancer. It is often used in conjunction with other antibodies for these specific cancers (Chu and Weiss, 2002).
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- Biological: Immunohistochemical staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: Immunohistochemical stainingOther
Staining of Colorectal Carcinoma tissue sections by monoclonal antibodies against Pan- cytokeratin by immunohistochemical procedures.
| Study group | Role | What they receive |
|---|---|---|
| paticipants | 50 archived Formalin-fixed Paraffin-embedded tissue blocks of Colorectal Carcinoma will be obtained and sectioned. From each block; Two tissue sections will be prepared, one tissue section will be stained by Hematoxylin and Eosin to detect tumor phenotype and depth of invasion. Other tissue section will be immunohistochemically stained by Pan-cytokeratin Receives: Other: Biological: Immunohistochemical staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Tumor Budding in Colorectal Adenocarcinoma
Histological assessment and immunohistochemical highlighting of tumor Budding by Pan-CK.
Measured: 6 months
Secondary outcomes (1)
Correlation of Tumor Budding with clinicopathological parameters
Correlation between different grades of Tumor Budding in Colorectal Carcinoma cells and some clinical and pathological parameters as age, sex, tumor phenotype and nodal status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion3 May 2026 (estimated)
- Study completion3 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaza Mostafa Galal Mostafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003776
- Sponsor's protocol ID
- Soh-Med--25-5-2MS
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wick MR, Cherwitz DL, McGlennen RC, Dehner LP. Adrenocortical carcinoma. An immunohistochemical comparison with renal cell carcinoma. Am J Pathol. 1986 Feb;122(2):343-52.
PubMed 2418689Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Mounir, A., Hassan, M. A., Selim, M. A., and Mahmoud, I. A. (2022). Epidemiology of Colorectal Cancer, Incidence, Survival, and Risk Factors: Cairo University Center of Oncology and Nuclear Medicine Experience. The Egyptian Journal of Hospital Medicine, 89(2), 7061-7070. https://doi.org/10.21608/ejhm.2022.272513
Masetti M, Fallani G, Ratti F, Ferrero A, Giuliante F, Cillo U, Guglielmi A, Ettorre GM, Torzilli G, Vincenti L, Ercolani G, Cipressi C, Lombardi R, Aldrighetti L, Jovine E. Minimally invasive treatment of colorectal liver metastases: does robotic surgery provide any technical advantages over laparoscopy? A multicenter analysis from the IGoMILS (Italian Group of Minimally Invasive Liver Surgery) registry. Updates Surg. 2022 Apr;74(2):535-545. doi: 10.1007/s13304-022-01245-1. Epub 2022 Jan 31.
PubMed 35099776Mishra, P. P., Madan, K., Biswas, S., Rao, A. C. K., Shetty, R., and Panda, P. (2022). Tumour budding in colorectal carcinoma: Association with other histopathological prognostic parameters. IP Archives of Cytology and Histopathology Research, 7(1), 26-31. https://doi.org/10.18231/j.achr.2022.006
Kyong Shin J, Ah Park Y, Wook Huh J, Hyeon Yun S, Cheol Kim H, Yong Lee W, Hyung Kim S, Yun Ha S, Cho YB. Is High-Grade Tumor Budding an Independent Prognostic Factor in Stage II Colon Cancer? Dis Colon Rectum. 2023 Aug 1;66(8):e801-e808. doi: 10.1097/DCR.0000000000002345. Epub 2022 Apr 5.
PubMed 35394982Giordano PG, Diaz Zelaya AG, Aguilera Molina YY, Taboada Mostajo NO, Ajete Ramos Y, Ortega Garcia R, Peralta de Michelis E, Meneu Diaz JC. Clinico-pathological evaluation of tumor budding in the oncological progression of colorectal cancer. Med Clin (Barc). 2024 Aug 30;163(4):159-166. doi: 10.1016/j.medcli.2024.02.017. Epub 2024 May 1. English, Spanish.
PubMed 38697893Chu PG, Weiss LM. Keratin expression in human tissues and neoplasms. Histopathology. 2002 May;40(5):403-39. doi: 10.1046/j.1365-2559.2002.01387.x.
PubMed 12010363Badzio A, Czapiewski P, Gorczynski A, Szczepanska-Michalska K, Haybaeck J, Biernat W, Jassem J. Prognostic value of broad-spectrum keratin clones AE1/AE3 and CAM5.2 in small cell lung cancer patients undergoing pulmonary resection. Acta Biochim Pol. 2019 Feb 22;66(1):111-114. doi: 10.18388/abp.2018_2773.
PubMed 30793712
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tumor Budding In Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07003776
- Acronym / sponsor ID
- Soh-Med--25-5-2MS
- Conditions
- Colorectal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 3 May 2026 (estimated)
- Study completion
- 3 May 2026 (estimated)
- First posted
- 4 Jun 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 cancer (CRC) is among the most prevalent cancers globally, with approximately one to two million new cases diagnosed each year. This makes CRC the third most common cancer and the fourth leading cause of cancer-related deaths, with 700,000 deaths per year, exceeded only by lung, liver and stomach cancers. CRC accounts for about 10% of all cancer diagnoses worldwide (Sung et al., 2021; Masetti et al., 2022) .
CRC affects different races and ethnicities at various age groups in distinct ways. Among patients younger than 50 years old, the proportion of CRC is nearly double for Black individuals (16%) compared to White individuals (9%) and Hispanic individuals (6%). In Egypt, CRC ranked the seventh among cancers, following lung, breast, prostate, liver, and bladder cancers (Mounir et al., 2022).
Tumor budding (TB) is characterized by the presence of individual tumor cells or small clusters of up to four cells at the invasive margin of a tumor. This histological feature, which indicates the separation of malignant cells from the main tumor mass, has intrigued pathologists since it was first identified in the 1950s (Giordano et al., 2024).
Evaluating TB is crucial for improving prognostic accuracy and informing treatment decisions. Tumors with high-grade TB exhibit a significantly lower 5-year Disease-Free Survival (DFS) rate compared to those with low-grade TB. High-grade TB is regarded as a negative prognostic factor and is associated with an increased risk of recurrence (Kyong Shin et al., 2023).
TB can be observed in conventional slides when prominent, but careful observation is necessary. A more thorough assessment of TB is more easily achieved if the neoplastic epithelium is highlighted using pan-cytokeratin immunostains (Mishra et al., 2022).
Pan-keratin (Pan-CK) antibodies are proteins derived from cytoskeletal intermediate filaments. These antibodies are a mixture designed to detect multiple low and high molecular weight keratins. Their primary purpose is to allow for the immunohistochemical identification of all epithelial cell types, regardless of their tissue of origin, using a single diagnostic tool.
In surgical pathology, Pan-CK antibodies are commonly used to confirm the epithelial origin of both neoplastic (tumorous) and non-neoplastic tissues, as well as to identify small metastases in lymph nodes. However, there are limitations to the assumption that Pan-CK antibodies will stain all epithelial tumors and that non-epithelial tissues will be "keratin negative." It has been reported that a diverse range of epithelial tumors can be Pan-CK negative, challenging the notion that these antibodies are universally applicable (Wick et al., 1986; Badzio, 2019).
Pan-CK can help diagnose disease like breast cancer, lung cancer, prostate cancer, and colorectal cancer. It is often used in conjunction with other antibodies for these specific cancers (Chu and Weiss, 2002).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paticipants | – | Other: Biological: Immunohistochemical staining50 archived Formalin-fixed Paraffin-embedded tissue blocks of Colorectal Carcinoma will be obtained and sectioned. From each block; Two tissue sections will be prepared, one tissue section will be stained by Hematoxylin and Eosin to detect tumor phenotype and depth of invasion. Other tissue section will be immunohistochemically stained by Pan-cytokeratin |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Archived Formalin-fixed, Paraffin-embedded tissue blocks belonged to patients suffered from colonic and/or rectal cancers. Patients were admitted to sohag university hospital and underwent colectomy and their colonic specimens were sent to Pathology Laboratory of the same hospital to ascertain diagnosis and tumor phenotype.
Key inclusion criteria (1 listed)
- Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.
Key exclusion criteria (1 listed)
- Tissue blocks with insufficient, destroyed or necrotic material. Specimens with insufficient clinical data.
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 |
|---|---|---|
| Biological: Immunohistochemical stainingStaining of Colorectal Carcinoma tissue sections by monoclonal antibodies against Pan- cytokeratin by immunohistochemical procedures. | Other | paticipants |
Primary outcome
Evaluation of Tumor Budding in Colorectal Adenocarcinoma
Time frame: 6 months
Histological assessment and immunohistochemical highlighting of tumor Budding by Pan-CK.
1 secondary outcome
Correlation of Tumor Budding with clinicopathological parameters
Time frame: 6 months
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 4 Jun 2025.
- Results publication: PubMed 2418689Wick MR, Cherwitz DL, McGlennen RC, Dehner LP. Adrenocortical carcinoma. An immunohistochemical comparison with renal cell carcinoma. Am J Pathol. 1986 Feb;122(2):343-52.
- Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Results publicationMounir, A., Hassan, M. A., Selim, M. A., and Mahmoud, I. A. (2022). Epidemiology of Colorectal Cancer, Incidence, Survival, and Risk Factors: Cairo University Center of Oncology and Nuclear Medicine Experience. The Egyptian Journal of Hospital Medicine, 89(2), 7061-7070. https://doi.org/10.21608/ejhm.2022.272513
- Results publication: PubMed 35099776Masetti M, Fallani G, Ratti F, Ferrero A, Giuliante F, Cillo U, Guglielmi A, Ettorre GM, Torzilli G, Vincenti L, Ercolani G, Cipressi C, Lombardi R, Aldrighetti L, Jovine E. Minimally invasive treatment of colorectal liver metastases: does robotic surgery provide any technical advantages over laparoscopy? A multicenter analysis from the IGoMILS (Italian Group of Minimally Invasive Liver Surgery) registry. Updates Surg. 2022 Apr;74(2):535-545. doi: 10.1007/s13304-022-01245-1. Epub 2022 Jan 31.
- Results publicationMishra, P. P., Madan, K., Biswas, S., Rao, A. C. K., Shetty, R., and Panda, P. (2022). Tumour budding in colorectal carcinoma: Association with other histopathological prognostic parameters. IP Archives of Cytology and Histopathology Research, 7(1), 26-31. https://doi.org/10.18231/j.achr.2022.006
- Results publication: PubMed 35394982Kyong Shin J, Ah Park Y, Wook Huh J, Hyeon Yun S, Cheol Kim H, Yong Lee W, Hyung Kim S, Yun Ha S, Cho YB. Is High-Grade Tumor Budding an Independent Prognostic Factor in Stage II Colon Cancer? Dis Colon Rectum. 2023 Aug 1;66(8):e801-e808. doi: 10.1097/DCR.0000000000002345. Epub 2022 Apr 5.
- Results publication: PubMed 38697893Giordano PG, Diaz Zelaya AG, Aguilera Molina YY, Taboada Mostajo NO, Ajete Ramos Y, Ortega Garcia R, Peralta de Michelis E, Meneu Diaz JC. Clinico-pathological evaluation of tumor budding in the oncological progression of colorectal cancer. Med Clin (Barc). 2024 Aug 30;163(4):159-166. doi: 10.1016/j.medcli.2024.02.017. Epub 2024 May 1. English, Spanish.
- Results publication: PubMed 12010363Chu PG, Weiss LM. Keratin expression in human tissues and neoplasms. Histopathology. 2002 May;40(5):403-39. doi: 10.1046/j.1365-2559.2002.01387.x.
- Results publication: PubMed 30793712Badzio A, Czapiewski P, Gorczynski A, Szczepanska-Michalska K, Haybaeck J, Biernat W, Jassem J. Prognostic value of broad-spectrum keratin clones AE1/AE3 and CAM5.2 in small cell lung cancer patients undergoing pulmonary resection. Acta Biochim Pol. 2019 Feb 22;66(1):111-114. doi: 10.18388/abp.2018_2773.
Related trials for Colorectal Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenocarcinoma, run by Sohag 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 4 Jun 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 Shaza Mostafa Galal, Demonstrator (01065273835, shaza.mostafa@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Tumor Budding in Colorectal Adenocarcinoma (time frame: 6 months). 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 NCT07003776, which also lists 9 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 4 Jun 2025.