Colorectal CancerPhase 2/3NCT05698082
FOS Immunohistochemical Staining of Colorectal Cancer and Its Adjacent Tissues
A Phase 2/3 study testing Immunohistochemical staining with anti-FOS in people with Colorectal Cancer and Monkey Pox, run by xiaoliang Huang at 1 site in China.
Trial summary
Colorectal cancer tissue sections were obtained according to the inclusion criteria. The formalin was used to immersed all cancer specimens. And tissues were cut to 5 μm thickness and placed on glass slides before staining. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Colorectal Cancer, Monkey Pox
- What is being tested?
- Immunohistochemical staining with anti-FOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Jan 2025
- Phase
- Phase 2/3
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a) patients with histologically confirmed CRC (b) patients who underwent resection of the primary tumor (c) patients at first visit who had not received treatment before blood testing.
Who cannot join
- (a) familial adenomatous polyposis or hereditary colon cancer (b) no signs of clinical infection, such as fever, on the day of blood collection; And (c) patients with multiple primary tumors during hospitalization.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Xiangliang Huang, Dr., +8613617713823, xiaoliang@sr.gxmu.edu.cn
About this study
Official title: Monkeypox and Cancer: a Pan-cancer Based Multi-omics Analysis and Single Cell Sequencing Analysis-Experimental Studies
Colorectal cancer tissue sections were obtained according to the inclusion criteria. The formalin was used to immersed all cancer specimens. And tissues were cut to 5 μm thickness and placed on glass slides before staining. Endogenous peroxidase activity was inhibited and blocked by de-paraffinizing, rehydrating, and using 5% bovine serum albumin at 37ºC for 30 min. The treated sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy.
- Conditions
- Colorectal Cancer, Monkey Pox
- Being tested
- Immunohistochemical staining with anti-FOS
- Keywords
- Differential expression of gene, Immunohistochemical staining, Tumor microenvironment
- Medical subject headings
- Colorectal Neoplasms, Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical staining with anti-FOSDiagnostic test
The tissue sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy.
| Study group | Role | What they receive |
|---|---|---|
| Test group-stained by FOS antibody | Experimental | Sixty colorectal cancer tissue sections were included. The tissue was cut to 5 μm thick and placed on a glass slide for staining. Endogenous peroxidase activity was inhibited and blocked by deparaffin, rehydration, and treatment with 5% bovine serum albumin for 30 min at 37 ° C. The treated sections were incubated with anti-FOS (promab 30360) overnight at 4 ° C and washed three times with PBS. After that, it was required to incubate with secondary anti-peroxidation sunflower for 30 min at 37 ° C. After washing three times with PBS, the images were developed in diamine benzidine and micrographs were obtained under a light microscope. Receives: Diagnostic Test: Immunohistochemical staining with anti-FOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Original survival
Time from the start of the study to death from any cause. For subjects who were lost to follow-up before death, the time of last follow-up was calculated as the time of death.
Measured: Participants were followed up for 3 years, including outpatient follow-up and telephone follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Dec 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiaoliang Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xiaoliang Huang, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698082
- Sponsor's protocol ID
- KY-2020-305
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monkeypox and Cancer: a Pan-cancer Based Multi-omics Analysis and Single Cell Sequencing Analysis-Experimental Studies
- ClinicalTrials.gov ID
- NCT05698082
- Acronym / sponsor ID
- KY-2020-305
- Conditions
- Colorectal Cancer, Monkey Pox
- Keywords
- Differential expression of gene, Immunohistochemical staining, Tumor microenvironment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- xiaoliang HuangUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Jan 2023 (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 tissue sections were obtained according to the inclusion criteria. The formalin was used to immersed all cancer specimens. And tissues were cut to 5 μm thickness and placed on glass slides before staining. Endogenous peroxidase activity was inhibited and blocked by de-paraffinizing, rehydrating, and using 5% bovine serum albumin at 37ºC for 30 min. The treated sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group-stained by FOS antibody | Experimental | Diagnostic Test: Immunohistochemical staining with anti-FOSSixty colorectal cancer tissue sections were included. The tissue was cut to 5 μm thick and placed on a glass slide for staining. Endogenous peroxidase activity was inhibited and blocked by deparaffin, rehydration, and treatment with 5% bovine serum albumin for 30 min at 37 ° C. The treated sections were incubated with anti-FOS (promab 30360) overnight at 4 ° C and washed three times with PBS. After that, it was required to incubate with secondary anti-peroxidation sunflower for 30 min at 37 ° C. After washing three times with PBS, the images were developed in diamine benzidine and micrographs were obtained under a light microscope. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (a) patients with histologically confirmed CRC (b) patients who underwent resection of the primary tumor (c) patients at first visit who had not received treatment before blood testing.
Key exclusion criteria (1 listed)
- (a) familial adenomatous polyposis or hereditary colon cancer (b) no signs of clinical infection, such as fever, on the day of blood collection; And (c) patients with multiple primary tumors during hospitalization.
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 |
|---|---|---|
| Immunohistochemical staining with anti-FOSThe tissue sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy. | Diagnostic test | Test group-stained by FOS antibody |
Primary outcome
Original survival
Time frame: Participants were followed up for 3 years, including outpatient follow-up and telephone follow-up.
Time from the start of the study to death from any cause. For subjects who were lost to follow-up before death, the time of last follow-up was calculated as the time of death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Immunohistochemical staining with anti-FOS in people with Colorectal Cancer and Monkey Pox, run by xiaoliang Huang at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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 China. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoliang Huang, Dr. (0086-13617713823, xiaoliang@sr.gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Original survival (time frame: Participants were followed up for 3 years, including outpatient follow-up and telephone follow-up.). 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 26 Jan 2023.