WGA in Platinum-refractory HNSCC Underwent Nivolumab

NCT03917537 | Unknown

• 1 other identifier: PRECISION-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

To choose a subgroup who could clearly benefit from Nivolumab, we are proposing a prospective observational study. Whole-genome study (WGS) analysis will be performed on archived cancer tissues from patients who were (1) cisplatin-refractory and subsequently (2) received Nivolumab (at least 4 doses) and (3) had completed imaging response evaluation at 3-4 month after Nivolumab. The estimated sample size was designed to be 80, including 20 responders and 60 non-responders (1:3 design) after Nivolumab alone at a dosage of 2-3mg/kg every 2 weeks (+/- 7 days could be allowed), given the minimal requirement of statistical significance. The specific bio-signature(s) found in this prospective observational study could possibly greatly contribute to precision immuno-oncology medicine, especially Nivolumab.

Conditions

HNSCC

Keywords

programmed death 1 (PD-1); programmed death ligand 1 (PD-1); Nivolumab; Pembrolizumab; immune-related adverse events (irAEs); whole-genome sequencing (WGS); Circulating tumor cells (CTCs); Platinum-refractory

Outcome Measures

Primary Outcomes (1)

• Prediction rate of Nivolumab Response

  Prediction rate of Nivolumab Response

  2-4 months

Secondary Outcomes (1)

• Adverse effects (types and grading) of Nivolumab

  2-4 months

Study Arms (1)

HNSCC patients have used Nivolumab

Retrospectively analyze WGS information from cancer tissues from HNSCC patients have used Nivolumab

Genetic: HNSCC patients have used Nivolumab

Interventions

HNSCC patients have used Nivolumab GENETIC

Using Whole-Genome Analysis on Cancer Tissue of Patients with Platinum-refractory Head and Neck Squamous cell carcinoma Who Underwent Nivolumab to Precisely Predict Responders: An Observational Biomarker Study

HNSCC patients have used Nivolumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospectively analyze WGS information from cancer tissues from HNSCC patients have used Nivolumab

You may qualify if:

• Age above 20 years old

You may not qualify if:

• Age below 20 years old

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. The study will retrieve cancer tissues from HNSCC patients received threshold Nivolumab. WGS by Illumina HighSeq X Ten Platform will be used for exploring biomarkers of Nivolumab. 2. All Samples will be collected from pathologic departments from participating hospitals, including 10μm x 5-10 slices non-coating, 3μm x 3 slices for PD-L1 staining. 3. Also, Pathologist will involve PD-L1 IHC staining (Ventana SP 263) and grading. 4. Cancer Tissues will be sent for WGS analysis (Application for sampling tests will be sent and obtained.) 5. Data will be sent to biostatistics analysis company or experts for analysis with charges.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Parkinson Disease 4, Autosomal Dominant Lewy Body; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tsang-Tang Hsieh, M.D.

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Jason Chia-Hsun Hsieh, M.D. Ph.D.

CONTACT

+886-33281200; wisdom3000cgmh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: April 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 25, 2019

Record last verified: 2018-07

Locations

TW (2)