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Trial record 60 of 364 for:    transthyretin

The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03240835
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University

Tracking Information
First Submitted Date July 27, 2017
First Posted Date August 7, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date September 12, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2017)
changes of PA/RBP/TRSF [ Time Frame: baseline and during treatment ]
to evaluate the changes of PA/RBP/TRSF during the treatment
Original Primary Outcome Measures
 (submitted: August 1, 2017)
changes of PA/CBP/TRSF [ Time Frame: baseline and during treatment ]
to evaluate the changes of PA/CBP/TRSF during the treatment
Change History Complete list of historical versions of study NCT03240835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 1, 2017)
  • Change of Body weight [ Time Frame: baseline and during treatment ]
    to compare the change of weight loss during treatment
  • Number of Participants With Abnormal Laboratory Values [ Time Frame: baseline and during treatment ]
    To observe the complete blood cell count and blood biochemical examination during treatment
  • Acute Toxicity [ Time Frame: baseline and during treatment ]
    To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients
Official Title The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy
Brief Summary The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III
Condition
  • Nasopharyngeal Carcinoma
  • Malnutrition
Intervention
  • Drug: cisplatin and docetaxel

    NACt:cisplatin 75 mg/m2 intravenous infusion in day1,docetaxel 75 mg/m2 intravenous infusion in day1,both drugs are given every 3 weeks, two cycles.

    CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.

  • Radiation: IMRT
    intensity modulation radiation therapy
Study Groups/Cohorts CCRT±NACT
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only
Interventions:
  • Drug: cisplatin and docetaxel
  • Radiation: IMRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 1, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
  • All genders,range from 18~60 years old
  • Karnofsky performance status(KPS) ≥ 80
  • Clinical stage III~IVb(UICC 8th)
  • Without significant digestive system disease,nutritional and metabolic diseases or endocrine disease
  • Without significant cardiac,respiratory,kidney or liver disease
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
  • white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
  • alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 1.5×upper limit of normal(ULN), bilirubin < 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
  • Inform consent form

Exclusion Criteria:

  • Distance metastases
  • Second malignancy within 5 years
  • Drug or alcohol addition
  • Do not have full capacity for civil acts
  • Active systemic infections
  • Chronic consumptions
  • Mental disorder
  • Pregnancy or lactation
  • Concurrent immunotherapy or hormone therapy for other diseases
  • Severe complication, eg, uncontrolled hypertension
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03240835
Other Study ID Numbers NPC-PA/RBP/TRSF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Zhao Chong, Sun Yat-sen University
Study Sponsor Zhao Chong
Collaborators Wu Jieping Medical Foundation
Investigators Not Provided
PRS Account Sun Yat-sen University
Verification Date February 2019