Identification of Breath Biomarkers in Esophageal Cancer

NCT ID: NCT05557955

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-27
• Study Completion Date: 2023-11-15

Brief 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.

Detailed 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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neoadjuvant chemoradiotherapy group

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.

Breathing test

Intervention Type: OTHER

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

Definitive chemoradiotherapy group

All patients will receive standard fractionation radiation therapy (RT) scheme: 50-50.4 Gy in 25-28 fractions over 5-6 weeks using intensity-modulated radiotherapy, concurrently with platinum- or taxane-based chemotherapy, with or without PD-1 inhibitors. Dynamic breathing testing was performed before, during, and after radiotherapy.

Breathing test

Intervention Type: OTHER

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

Interventions

Breathing test

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mian XI

OTHER

Sponsor Role: lead

Responsible Party

Mian XI

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ruihua Xu, MD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Mian Xi

Guangzhou, Guangdong, China

Countries

China

References

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/j.eclinm.2022.101384. eCollection 2022 May.

Reference Type: RESULT

PMID: 35480076 (View on PubMed)

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: 10.1001/jamanetworkopen.2021.3486.

Reference Type: RESULT

PMID: 33783517 (View on PubMed)

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. doi: 10.1001/jamaoncol.2018.0991.

Reference Type: RESULT

PMID: 29799976 (View on PubMed)

Other Identifiers

B2022-474-01

Identifier Type: -

Identifier Source: org_study_id