Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation

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

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-12-11

Brief Summary

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This is a prospective, single arm, single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July\~ 2019 June. Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D \& CIPN20). The primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients.

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Detailed Description

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Conditions

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Chemotherapy-induced Abnormal Thermal Sensation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with endometrial or ovarian cancer

Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI

Intervention Type DIAGNOSTIC_TEST

Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.

Patients with colorectal cancer

Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI

Intervention Type DIAGNOSTIC_TEST

Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.

Interventions

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Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI

Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 20 years old
* Pathological stage I\~IV for ovarian cancer, stage II\~IV for endometrial cancer, or stage III for colorectal cancer.
* Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer.
* Patient willing to provide blood sample for research purposes.
* Ability of the patient to provide informed consent.

Exclusion Criteria

* Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids.
* Receiving chemotherapy within 6 months.
* A family history of a genetic or familial neuropathy
* Poor compliance

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No