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

NCT ID: NCT03149978

Last Updated: 2017-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-01

Study Completion Date

2020-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Locally Advanced Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhu Ji

OTHER

Sponsor Role lead

Responsible Party

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Zhu Ji

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ji Zhu, MD

Role: CONTACT

+86-2164175590

Facility Contacts

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Ji Zhu, MD

Role: primary

References

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Jia H, Shen X, Guan Y, Xu M, Tu J, Mo M, Xie L, Yuan J, Zhang Z, Cai S, Zhu J, Zhu Z. Predicting the pathological response to neoadjuvant chemoradiation using untargeted metabolomics in locally advanced rectal cancer. Radiother Oncol. 2018 Sep;128(3):548-556. doi: 10.1016/j.radonc.2018.06.022. Epub 2018 Jul 2.

Reference Type DERIVED
PMID: 30041962 (View on PubMed)

Other Identifiers

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FDRT-006

Identifier Type: -

Identifier Source: org_study_id

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