Detection and Investigation of ctDNA with the Guardant Reveal System in Esophageal Cancer: Post-operative ObserVational Study of Esophageal CanceR

JRCT ID: jRCT1071240001

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 03/04/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: Predicted recurrence-free positive diagnostic rate in postoperative 28-day ctDNA-negative cases

Secondary Outcome

Predicted recurrence-free positive diagnostic rate in postoperative 28-day ctDNA-negative cases (including cases under non operative management)
Predicted recurrence positive diagnostic rate in postoperative 28-day ctDNA-positive cases (including cases under non operative management)
Predicted recurrence positive diagnostic rate in ctDNA-positive cases at any timepoints (including cases under non operative management)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Age at the time of obtaining consent is 20 years or older
2.Written consent to participate in the study has been provided by the patient himself/herself.
3.The patient was judged as being appropriate to be managed under the study protocol by the investigators.
4.The patient was diagnosed with esophageal cancer based on histological diagnosis of the primary lesion (including as followed: squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma).
5.Clinical stage I-IV according to the TNM classification (UICC-TNM 8th edition)
I.For stageI, cN1 can be enrolled.
II.cStageIVA (T4a, T4b) is for patients who can undergo R0 resection.
III.cStageIVB patients with positive supraclavicular lymph nodes (104) can be enrolled if cervical dissection is performed and R0 is achieved.
6. Patients scheduled for one-stage radical resection and reconstructive surgery (Mckeown or Ivor-Lewis).
7.No prior surgical treatment for esophageal cancer.
8.Any regimens are acceptable for preoperative chemotherapy and chemoradiotherapy.
9.ECOG scale : PS 0-2
10.The patient does not have severe impairment of major organ function and is suitable for surgery and postoperative observation.

Exclude criteria

1.Endoscopic treatment as prior therapy is excluded (advanced cancer as the primary lesion is acceptable for enrollment).
2.Transabdominal resection and reconstruction are excluded.
3.Patients with clinically problematic psychiatric disorders, history of central nervous system disorders, or comorbidities that make it difficult for the patient to return to the hospital (i.e., difficulty with periodic visits for laboratory tests (blood sampling)).
4.Patients with active multiple primary cancers (Patients with completely resected basal cell carcinoma, Stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma, superficial bladder cancer, or a history of other cancers that have not recurred for at least 5 years may be enrolled.)
5.Patients who are judged being inappropriate to participate in the study by the investigators.

Related Information

• Primary Sponsor: OKI Eiji
• Source(s) of Monetary Support: Kyushu Studygroup of Clinical Cancer