Metastatic Colorectal CancerNCT04230018
The Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2018to 27 Dec 2021
- 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: Patients with postoperative heterochronous metastasis,who has histologically confirmed metastatic colorectal adenocarcinoma and metastases could be punctured by interventional evaluation.In addittion,patients' blood ctDNA and tissues can be used to detect genetic mutations.
Who may be able to join
- Age ≥ 18 years old and ≤ 75 years old, both men and women;
- Patients must have histologically confirmed metastatic colorectal adenocarcinoma and metastases can be punctured by interventional evaluation;
- ECOG: 0 to 2;
- Expected survival ≥ 12 weeks;
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; Hemoglobin ≥ 8g / dL; Platelets ≥100×109/L;(According to the normal value of the clinical trial center)
- Prothrombin time (PT) < 1.5 times the upper normal limit and thrombin time (APTT) < 1.5 times the upper normal limit;
- Informed consent has been signed.
Who cannot join
- Patients had surgery within three weeks will be excluded.
- Patients have known or suspected brain metastases will be excluded.
- Pregnant or nursing women will be excluded.
- Patients with severe uncontrolled systemic disease, such as severe active infection, will be excluded.
- Patients had other malignancies in the past 5 years will be excluded, except cervical carcinoma in situ or basal cell carcinoma of the skin.
- Patients who were unable to complete the study or sign valid informed consent for medical, social or psychological reasons, which will be determined by researcher, will be excluded.
- Organ transplant recipients who need immunosuppressive therapy will be excluded.
- People have been known to be infected with immunodeficiency virus (HIV) or have been known to be serologically positive for HIV will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD, PhD
Feng Wang, MD, PhD, 86-2087343795, wangfeng@sysucc.org.cn
About this study
Official title: A Study Comparing the Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
Read the detailed description
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents. Now NCCN guidelines recommend targeted drugs for the treatment of metastatic colorectal cancer mainly including cetuximab and panizumab whic targeting EGFR , as well as the bevacizumab and arber regofini, etc which targeing anti-angiogenic.Cetuximab and panizumab are only effective in patients with RAS wild type.
Previous studies have shown that In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
Therefore, it has important clinical significance to compare the difference of gene profile between metastatic lesion and primary lesion in patients with postoperative metastasis of stage III colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC, primary focus, metastasis, heterogeneous metastasis, gene
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| primary and metastasis lesion | tissue of colorectal cancer primary lesion and tissue of colorectal cancer metastasis were obtained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis
We do NGS sequencing of both the primary and metastatic tissue sample of the CRC patients. The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be compared.
Measured: through study completion, an average of 2 years.
Secondary outcomes (1)
Mutation Consistency of tissue and blood sample
The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be reported. The consistency between the gene mutation of ctDNA test in blood and the gene mutation of tissue test is analyzed to determine whether the blood ctDNA test could replace the tissue gene test
Measured: through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start28 Dec 2018
- Primary completion27 Dec 2021 (estimated)
- Study completion27 Dec 2021 (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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Rui-hua Xu, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230018
- Sponsor's protocol ID
- Gene primary versus metastases
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siyar Ekinci A, Demirci U, Cakmak Oksuzoglu B, Ozturk A, Esbah O, Ozatli T, Celik B, Budakoglu B, Turker I, Bal O, Turan N. KRAS discordance between primary and metastatic tumor in patients with metastatic colorectal carcinoma. J BUON. 2015 Jan-Feb;20(1):128-35.
PubMed 25778307
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04230018
- Acronym / sponsor ID
- Gene primary versus metastases
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC, primary focus, metastasis, heterogeneous metastasis, gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 27 Dec 2021 (estimated)
- Study completion
- 27 Dec 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
Detailed description
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents. Now NCCN guidelines recommend targeted drugs for the treatment of metastatic colorectal cancer mainly including cetuximab and panizumab whic targeting EGFR , as well as the bevacizumab and arber regofini, etc which targeing anti-angiogenic.Cetuximab and panizumab are only effective in patients with RAS wild type.
Previous studies have shown that In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
Therefore, it has important clinical significance to compare the difference of gene profile between metastatic lesion and primary lesion in patients with postoperative metastasis of stage III colorectal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary and metastasis lesion | – | –tissue of colorectal cancer primary lesion and tissue of colorectal cancer metastasis were obtained |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with postoperative heterochronous metastasis,who has histologically confirmed metastatic colorectal adenocarcinoma and metastases could be punctured by interventional evaluation.In addittion,patients' blood ctDNA and tissues can be used to detect genetic mutations.
Key inclusion criteria (7 listed)
- Age ≥ 18 years old and ≤ 75 years old, both men and women;
- Patients must have histologically confirmed metastatic colorectal adenocarcinoma and metastases can be punctured by interventional evaluation;
- ECOG: 0 to 2;
- Expected survival ≥ 12 weeks;
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; Hemoglobin ≥ 8g / dL; Platelets ≥100×109/L;(According to the normal value of the clinical trial center)
Key exclusion criteria (8 listed)
- Patients had surgery within three weeks will be excluded.
- Patients have known or suspected brain metastases will be excluded.
- Pregnant or nursing women will be excluded.
- Patients with severe uncontrolled systemic disease, such as severe active infection, will be excluded.
- Patients had other malignancies in the past 5 years will be excluded, except cervical carcinoma in situ or basal cell carcinoma of the skin.
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
Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis
Time frame: through study completion, an average of 2 years.
We do NGS sequencing of both the primary and metastatic tissue sample of the CRC patients. The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be compared.
1 secondary outcome
Mutation Consistency of tissue and blood sample
Time frame: through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 25778307Siyar Ekinci A, Demirci U, Cakmak Oksuzoglu B, Ozturk A, Esbah O, Ozatli T, Celik B, Budakoglu B, Turker I, Bal O, Turan N. KRAS discordance between primary and metastatic tumor in patients with metastatic colorectal carcinoma. J BUON. 2015 Jan-Feb;20(1):128-35.
- 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.
Rui-hua Xu, PhD principal investigator
Sun Yat-sen University
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 Metastatic Colorectal Cancer, run by Sun Yat-sen University 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 7 inclusion and 8 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 22 Jan 2020. 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 Feng Wang, PhD (86-2087343795, wangfeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis (time frame: through study completion, an average of 2 years.). 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 NCT04230018, 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 22 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.