NCT05900583

Brief Summary

This project is focusing on who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. The exclusive MRD (Minimal residual disease) probe consists of an exclusive "molecular label" formulated according to the individual genome mutation profile and 21 critical tumor driver genes. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

May 12, 2023

Last Update Submit

June 10, 2023

Conditions

Minimal Residual DiseaseEsophageal Squamous Cell Carcinoma

Keywords

Minimal Residual DiseaseEsophageal Squamous Cell CarcinomaEfficacy EvaluationRecurrence Monitoring

Outcome Measures

Primary Outcomes (1)

  • pathological complete response (pCR)

    No residual tumor is the esophagus or dissected lymph nodes.

    immediately after surgery

Secondary Outcomes (2)

  • Recurrence-free survival (RFS)

    2 years

  • Overall survival (OS)

    2 years

Study Arms (2)

MRD positive group

MRD negative group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with locally advanced esophageal squamous cell carcinoma by imaging or pathological examination: cT2-4N1-3M0, cT3-4N0M0 II-IVA (including IVB stage with supraclavicular and abdominal lymph node metastasis);.

You may qualify if:

  • Age range from 18 to 80 years old;
  • Patients diagnosed with locally advanced esophageal squamous cell carcinoma by imaging or pathological examination: cT2-4N1-3M0, cT3-4N0M0 II-IVA (including IVB stage with supraclavicular and abdominal lymph node metastasis);
  • Receive neoadjuvant therapy;
  • Must be able to obtain the patient's clinical information and clear pathological diagnosis results;
  • Able to cooperate with long-term follow-up, regular review, and blood sample collection;
  • Patients agree to participate in the tracking and follow-up of the group and provide follow-up information;
  • Must obtain the informed consent of the patient or their legal representative, and the patient has the ability to cooperate to complete the requirements of the study.

You may not qualify if:

  • Patients with other cancers or severe illnesses that result in shorter survival than the trial follow-up period;
  • Received other treatments (such as radiotherapy, etc.) before receiving neoadjuvant therapy;
  • Have contraindications to chemotherapy;
  • Patients who received blood transfusions within three months prior to enrollment;
  • HIV-positive patients or those with other immune system deficiency diseases;
  • Pregnant patients;
  • Alcohol or drug abusers;
  • Other situations that the researchers believe may affect the experimental results or are unethical.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Neoplasm, ResidualEsophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 12, 2023

Study Start

June 1, 2023

Primary Completion

May 1, 2025

Study Completion

August 31, 2025

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)