Clinical trial NCT03679039: A Model for Predicting the Efficacy of Conversion Therapy for Patients With Colorectal Cancer Liver Metastases by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA
Official title: A Single-centre, Prospective, Cohort Trial of the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA for Establishing a Model for Predicting the Efficacy of Conversion Therapy for Patients With Unresectable Colorectal Cancer Liver Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer With Liver Metastases
Keywords: colorectal cancer
liver metastases
conversion therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable liver metastases from colorectal cancer were not received any anti-tumor therapy before being enrolled.

Brief summary: In this study, the investigators establish a model for predicting the efficacy of conversion therapy for the patients with unresectable liver metastases of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group.

Detailed description: Radical resection is the preferred treatment of colorectal cancer patients with liver metastasas which significantly reduce the survival. However, the majority of the patients cannot receive liver lesions resection resulting from the size, number and bad location. Conversion therapy can improve the resection rate of these patients. Unfortunately, the efficacy of conversion therapy is still poor in part of the patients. So, it is crucial to distinguish the beneficial ones from the others.

The aim of this single center study is to establish a model for predicting the efficacy of conversion therapy for the patients with unresectable liver metastases of colorectal cancer based on the detection of 5-hmC. Patients will be eligible for inclusion if they suffer with unresectable liver metastases of colorectal cancer and have not received any anti-tumor treatment. Eligible patients will be assigned to effective group (group A) and drug resistance group (group B) according to the evaluation results of multidisciplinary team after 4-8 cycles of conversion therapy about 2-4 months.

Then, 5-hmC in plasma cell-free DNA will be detected and compared between the two groups of patients (training group) to establish a model to predict the efficacy of convertion therapy of other individuals (validation group) who suffer with unresectable liver metastases of colorectal cancer receiving conversion therapy.

Eligibility criteria: Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma
* Liver metastases were observed by abdominal pelvic CT and / or MRI with/without other distant metastases
* The liver metastases assessed as unresectable lesions by multidisciplinary team
* No other malignancies in medical history
* Eastern cooperative oncology group score 0-2
* Informed consent

Exclusion Criteria:

* Patients received chemoradiotherapy or other anti-tumor therapy before being enrolled
* Patients and/or family members can not understand or accept this study
* Familial Adenomatous Polyposis, Lynch Syndrome, acute inflammatory bowel disease
* Pregnancy or lactation
* Unsuitable to take part in the clinical trial judged by doctors

Primary outcomes:
measure: The sensitivity and specificity of the model to predict the drug resistance
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: