Identification of Breath Biomarkers in Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

— EC-CRT-005  

Official title:

Predicting Clinical Outcomes Based on Dynamic Breathomics Testing in Esophageal Squamous Cell Carcinoma Receiving Chemoradiotherapy: A Prospective Observational Study (EC-CRT-005)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05557955
• Other study ID #: B2022-474-01
• Status: Completed
• Start date: September 27, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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. All patients will receive standard fractionation radiation therapy (RT) scheme: 40-50.4 Gy in 20-28 fractions over 4-6 weeks using intensity-modulated radiotherapy, concurrently with platinum- or taxane-based chemotherapy, with or without PD-1 inhibitors. All patients will undergo esophagectomy 6-8 weeks after the completion of neoadjuvant CRT. Dynamic breathing testing was performed before, during, and after radiotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 15, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the esophagus;

2. Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);

3. Age at diagnosis >18 years;

4. No prior cancer therapy;

5. Estimated life expectancy >6 months;

6. Eastern Cooperative Oncology Group performance status = 2

7. No history of concomitant or previous malignancy;

8. 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;

9. Ability to understand the study and sign informed consent.

Exclusion Criteria:

1. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);

2. Patients with hematogenous metastasis disease at diagnosis;

3. Female patients who are pregnant or lactating;

4. Inability to provide informed consent due to psychological, familial, social and other factors;

5. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.

6. The physical condition is not enough to provide 0.5L exhalation at one time.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Other:
• Breathing test
Dynamic breathing testing will be performed before, during, and after radiotherapy. Volatile organic compounds (VOCs) will be collected.

Locations

Country	Name	City	State
China	Mian Xi	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Mian XI

Country where clinical trial is conducted

China, 

References & Publications (3)

Markar SR, Wiggins T, Antonowicz S, Chin ST, Romano A, Nikolic K, Evans B, Cunningham D, Mughal M, Lagergren J, Hanna GB. Assessment of a Noninvasive Exhaled Breath Test for the Diagnosis of Oesophagogastric Cancer. JAMA Oncol. 2018 Jul 1;4(7):970-976. do — View Citation

Meng S, Li Q, Zhou Z, Li H, Liu X, Pan S, Li M, Wang L, Guo Y, Qiu M, Wang J. Assessment of an Exhaled Breath Test Using High-Pressure Photon Ionization Time-of-Flight Mass Spectrometry to Detect Lung Cancer. JAMA Netw Open. 2021 Mar 1;4(3):e213486. doi: — View Citation

Wang P, Huang Q, Meng S, Mu T, Liu Z, He M, Li Q, Zhao S, Wang S, Qiu M. Identification of lung cancer breath biomarkers based on perioperative breathomics testing: A prospective observational study. EClinicalMedicine. 2022 Apr 16;47:101384. doi: 10.1016/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival.	A predictive model based on exhaled volatile organic compounds to predict overall survival.	From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months.
Secondary	clinical complete response.	A predictive model based on exhaled volatile organic compounds to predict clinical complete response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies. RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response.	3 months after the treatment (plus or minus 7 days)
Secondary	recurrence.	A predictive model based on exhaled volatile organic compounds to predict recurrence.	From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.