Colorectal Cancer Stage IIINCT04714814
Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
An observational study of Colorectal Cancer Stage III and Colorectal Cancer Stage IV, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
This is a two stage nested case-control study to construct the hologram plane , explore biomarkers and screening original drugs of metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Stage III, Colorectal Cancer Stage IV
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 May 2023
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with CRC (Stage III and Stage IV)
Who may be able to join
- Baseline population (stage III colorectal cancer) inclusion criteria:
- Aged 18-75.
- Physical condition (ECOG) score ≤ 1.
- Colorectal adenocarcinoma was confirmed by histopathology.
- No family history of hereditary tumor.
- Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
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- Preoperative clinical stage is stage III.
- Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
- Enough primary surgical or biopsy tissues for examination.
- Enough peripheral blood samples for examination.
- Agree to sign informed consent to participate in this project.
- Baseline population (stage Ⅳ colorectal cancer) inclusion criteria:
- Aged 18-75.
- Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
- Not yet received antineoplastic therapy.
- Baseline imaging evaluation shows at least one measurable focus.
- Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination.
- Enough peripheral blood samples for examination.
- Expected survival time ≥ 3 months.
- Provide information such as demography, current medical history or current tumor disease, pathological diagnosis and staging of tumor, physical status of ECOG, radiographic evaluation of tumor, etc.
- Agree to sign informed consent to participate in this project.
- Metastasis colorectal cancer cohort study inclusion criteria:
- Aged 18-75.
- Physical condition (ECOG) score ≤ 1.
- Colorectal adenocarcinoma was confirmed by histopathology.
- No family history of hereditary tumor.
- Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
- Preoperative clinical stage is stage III and the postoperative pathological stage was confirmed as stage III.
- Agreed to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
- Enough primary surgical or biopsy tissues for examination.
- Enough peripheral blood samples for examination.
- Agree to sign informed consent to participate in this project.
Who cannot join
- Baseline population (stage III colorectal cancer) exclusion criteria:
- Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
- Postoperative pathological stage was confirmed as stage II.
- Abnormal function of heart, lung, liver, kidney, hematopoiesis or bone marrow reserve, which cannot tolerate operation or chemotherapy.
- Diagnosed with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
- Having mental illness or other serious cardiovascular diseases.
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- Pregnancy or lactation or planned pregnancy within one year.
- Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
- Baseline population (stage Ⅳcolorectal cancer) exclusion criteria:
- Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
- Nervous system metastasis.
- Complicated with other malignant tumors.
- Having poorly controlled chronic concomitant diseases that affect the prognosis.
- Any complication that may affect the results of the study .
- Metastasis colorectal cancer cohort study exclusion criteria:
- Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
- Abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which cannot tolerate operation and chemotherapy.
- Diagnoses with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
- Having mental illness or other serious cardiovascular disease.
- Pregnancy or lactation or planned pregnancy within one year.
- Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospttal
Shanghai, Sahgnhai, 200000
Yanye Yang, Bachelor, +86-13636419858, young0503@163.com
About this study
Official title: a Multi-omics Cohort Study of Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
This is a two stage nested case-control study to construct the hologram plane , explore biomarkers and screening original drugs of metastatic colorectal cancer.
Read the detailed description
Stage Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 200 colorectal cancer cases( at least 160 stage Ⅲ cases,40 stage Ⅳ（synchronous metastasis）).Stage Ⅱ is a nested case-control study. 200 eligible cases enrolled in phaseⅠwill be followed up for 5 years to record recurrence, metastasis and to collect biospecimen . Each case with the study outcome will be matched with the corresponding control according to the proportion of 1:1 according to age, sex and other conditions, and further analysis will be made.
- Keywords
- Colorectal , Metastatisis ,Cancer Cell Fate Regulatory Mechanism
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence or metastasis provened by imageologic diagnosis (PFS)
tumor metastasis or progression occurred during the enrolment period
Measured: May 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Stage IIIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, RenJi Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Sun Jing, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714814
- Sponsor's protocol ID
- Metastatic CRC cell fate
- Status last verified
- Mar 2021
- First submitted
- 12 Jan 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou X, Lin J, Shao Y, Zheng H, Yang Y, Li S, Fan X, Hong H, Mao Z, Xue P, Zhang S, Sun J. Targeting PLCG2 Suppresses Tumor Progression, Orchestrates the Tumor Immune Microenvironment and Potentiates Immune Checkpoint Blockade Therapy for Colorectal Cancer. Int J Biol Sci. 2024 Oct 14;20(14):5548-5575. doi: 10.7150/ijbs.98200. eCollection 2024.
PubMed 39494327
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multi-omics Cohort Study of Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
- ClinicalTrials.gov ID
- NCT04714814
- Acronym / sponsor ID
- Metastatic CRC cell fate
- Keywords
- Colorectal , Metastatisis ,Cancer Cell Fate Regulatory Mechanism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, RenJi Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 19 Jan 2021 (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.
This is a two stage nested case-control study to construct the hologram plane , explore biomarkers and screening original drugs of metastatic colorectal cancer.
Detailed description
Stage Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 200 colorectal cancer cases( at least 160 stage Ⅲ cases,40 stage Ⅳ（synchronous metastasis）).Stage Ⅱ is a nested case-control study. 200 eligible cases enrolled in phaseⅠwill be followed up for 5 years to record recurrence, metastasis and to collect biospecimen . Each case with the study outcome will be matched with the corresponding control according to the proportion of 1:1 according to age, sex and other conditions, and further analysis will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with CRC (Stage III and Stage IV)
Key inclusion criteria (32 listed)
- Baseline population (stage III colorectal cancer) inclusion criteria:
- Aged 18-75.
- Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
- Not yet received antineoplastic therapy.
- Baseline imaging evaluation shows at least one measurable focus.
Key exclusion criteria (21 listed)
- Baseline population (stage III colorectal cancer) exclusion criteria:
- Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
- Nervous system metastasis.
- Complicated with other malignant tumors.
- Having poorly controlled chronic concomitant diseases that affect the prognosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
recurrence or metastasis provened by imageologic diagnosis (PFS)
Time frame: May 31, 2023
tumor metastasis or progression occurred during the enrolment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 39494327Zhou X, Lin J, Shao Y, Zheng H, Yang Y, Li S, Fan X, Hong H, Mao Z, Xue P, Zhang S, Sun J. Targeting PLCG2 Suppresses Tumor Progression, Orchestrates the Tumor Immune Microenvironment and Potentiates Immune Checkpoint Blockade Therapy for Colorectal Cancer. Int J Biol Sci. 2024 Oct 14;20(14):5548-5575. doi: 10.7150/ijbs.98200. eCollection 2024.
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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.
Sun Jing, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Stage III and Colorectal Cancer Stage IV, run by Shanghai Minimally Invasive Surgery Center 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 32 inclusion and 21 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 23 Mar 2021. 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.
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 Sun Jing, PhD (13524284622, sj11788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence or metastasis provened by imageologic diagnosis (PFS) (time frame: May 31, 2023). 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 NCT04714814, which also lists 1 linked publication.
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 23 Mar 2021.