Molecular Study and Precision Medicine for Colorectal Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

Researchers collect specimens from advanced or recurrent colorectal cancer (CRC) patients to conduct molecular profiling and establish tumor organoids (PDOs)/ patient-derived xenografts (PDXs). The aim of this study is to identify clinical actionable targets and predict in vivo response of the tumor to targeted drugs by using PDOs/ PDXs. And the above-mentioned studies will provide the patients with potential personalized cancer treatment options.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients, age 18 to 75 years old

Patients with a documented (histologically- or cytologically-proven) advanced or recurrent colorectal cancer

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months

Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.

Disqualifiers

Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug

Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy

Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first study drug administration.

Patients with a history of human immunodeficiency virus (HIV) or any other immunodeficiency disease.

Trial population

patients with advanced or recurrent colorectal cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Molecular Profiling & drug testing in tumor organoids and PDXs

    Other intervention

    Molecular profiling of native tumor will be performed and analyzed by using a self-designed panel. Tumor organoids will be cultured from fresh tumor tissues and patient-derived xenografts model will be established using the tumor organoids. Drugs will be tested in the two models. And the recommendation will be communicated to the clinicians.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Colorectal Cancer1 intervention

Trial outcomes

Primary outcomes

1

Identification of effective drugs or drug combinations

Viability of organoid is measured using CellTiter-Glo by quantifying ATP, which indicates the presence of metabolically active cells.

Time frame
up to 3 years

Secondary outcomes

1

Comparison of clinical actionable alterations identified in native tumor and organoids.

Genomic gene mutation numbers are identified using the Next-Generation Sequencing (NGS).

Time frame
Up to 3 years
2

Correlation between organoid and PDX drug sensitivities

Size of the tumor is measured to reflect the drug response.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: