The Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer

NCT04230018 | Unknown DMC

• 1 other identifier: Gene primary versus metastases
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

mCRC; primary focus; metastasis; heterogeneous metastasis; gene

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 2 years.

Secondary Outcomes (1)

• Mutation Consistency of tissue and blood sample

  through study completion, an average of 2 years.

Other Outcomes (1)

• prediction accuracy of survival rate

  through study completion, an average of 2 years.

Study Arms (1)

primary and metastasis lesion

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25778307 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rui-hua Xu, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang, PhD

CONTACT

86-2087343795; wangfeng@sysucc.org.cn

Zhida Lv, BS

CONTACT

86-2087343795; lvzd@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Chief Physician, headof Gastroenterology, Professor#Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: January 18, 2020
• Study Start: December 28, 2018
• Primary Completion: December 27, 2021
• Study Completion: December 27, 2021
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)