The Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer

NCT ID: NCT04230018

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2021-12-27

Brief 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 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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

primary and metastasis lesion

tissue of colorectal cancer primary lesion and tissue of colorectal cancer metastasis were obtained

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old and ≤ 75 years old, both men and women;

2. Patients must have histologically confirmed metastatic colorectal adenocarcinoma and metastases can be punctured by interventional evaluation;

3. ECOG: 0 to 2;

4. Expected survival ≥ 12 weeks;

5. 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)

6. Prothrombin time (PT) < 1.5 times the upper normal limit and thrombin time (APTT) < 1.5 times the upper normal limit;

7. Informed consent has been signed.

Exclusion Criteria

1. Patients had surgery within three weeks will be excluded.

2. Patients have known or suspected brain metastases will be excluded.

3. Pregnant or nursing women will be excluded.

4. Patients with severe uncontrolled systemic disease, such as severe active infection, will be excluded.

5. Patients had other malignancies in the past 5 years will be excluded, except cervical carcinoma in situ or basal cell carcinoma of the skin.

6. 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.

7. Organ transplant recipients who need immunosuppressive therapy will be excluded.

8. People have been known to be infected with immunodeficiency virus (HIV) or have been known to be serologically positive for HIV will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Xu

Dean, Chief Physician, headof Gastroenterology, Professor#Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui-hua Xu, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Wang, PhD

Role: CONTACT

wangfeng@sysucc.org.cn

86-2087343795

Zhida Lv, BS

Role: CONTACT

lvzd@sysucc.org.cn

86-2087343795

Facility Contacts

Rui-Hua Xu, MD, PhD

Role: primary

Feng Wang, MD, PhD

Role: backup

wangfeng@sysucc.org.cn

86-2087343795

References

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.

Reference Type: BACKGROUND

PMID: 25778307 (View on PubMed)

Other Identifiers

Gene primary versus metastases

Identifier Type: -

Identifier Source: org_study_id