Identification of Breath Biomarkers in Esophageal Cancer

NCT05557955 | Completed DMC

• 1 other identifier: B2022-474-01
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Dynamic breathomics testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• clinical complete response.

  3 months after the treatment (plus or minus 7 days)

• 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.

Study Arms (2)

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.

Other: Breathing test

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.

Other: Breathing test

Interventions

Breathing test OTHER

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

Definitive chemoradiotherapy group; Neoadjuvant chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 230 patients with ESCC who undergo neoadjuvant chemoradiotherapy or definitive radiotherapy will be included.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
• Patients with hematogenous metastasis disease at diagnosis;
• Female patients who are pregnant or lactating;
• Inability to provide informed consent due to psychological, familial, social and other factors;
• 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.

Sponsors & Collaborators

• Mian XI: lead

Study Sites (1)

Mian Xi

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

• 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.

  PMID: 35480076 RESULT

• 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.

  PMID: 33783517 RESULT

• 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.

  PMID: 29799976 RESULT

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Ruihua Xu, MD

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 28, 2022
• Study Start: September 27, 2022
• Primary Completion: October 31, 2023
• Study Completion: November 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)