NCT05557955Completed
Identification of Breath Biomarkers in Esophageal Cancer
Predicting Clinical Outcomes Based on Dynamic Breathomics Testing in Esophageal Squamous Cell Carcinoma Receiving Chemoradiotherapy: A Prospective Observational Study (EC-CRT-005)
Source: ClinicalTrials.gov · Last updated 18 Nov 2023
Brief summary (registry, in English)
Neoadjuvant chemoradiotherapy (CRT) followed by surgery or definitive CRT is the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC), but the clinical outcomes are not satisfactory. Breathomics testing is a promising, non-invasive, simple method for detection and screening for ESCC. This observational study aimed to role of exhaled volatile organic compounds (VOCs) in predicting the efficacy and risk of recurrence in patients with locally advanced ESCC who received CRT.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 210 (actual)
- First submitted
- 24 Sept 2022
- Start date
- 27 Sept 2022
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- Mian XI
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05557955
What you commit to
- Study type: Observational
- Participants enrolled: 210
- From 27 Sept 2022 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
Other illness
- Patients with hematogenous metastasis disease at diagnosis;
- Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.
- The physical condition is not enough to provide 0.5L exhalation at one time.
Other
- Female patients who are pregnant or lactating;
- Inability to provide informed consent due to psychological, familial, social and other factors;
Who the study is looking for
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
- Age at diagnosis \>18 years;
- No prior cancer therapy;
- Estimated life expectancy \>6 months;
- Eastern Cooperative Oncology Group performance status ≤ 2
- No history of concomitant or previous malignancy;
- The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min;
- Ability to understand the study and sign informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mian Xi Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.