Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis

Zhu Ji

Status: Unknown

Conditions: Locally Advanced Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03149978

FDRT-006

Details and patient eligibility

About

This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. history of primary rectal cancer with distance from anal verge being less than 12 cm;
2. histologically confirmed adenocarcinoma;
3. initial pathological stage of T3 or T4 and/or N+;
4. no history of initial distant metastases;
5. Karnofsky Performance Status score of ≥75
6. ≥18 years;≤75 years
7. sign the inform consent

Exclusion criteria

1. pregnancy or breast-feeding women
2. serious medical illness
3. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN