TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer

NCT04939103 | Completed FDA Device

• 1 other identifier: luoyanxin
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is one of the most malignancies worldwide. The dominant clinical research strategy of LARC includes neoadjuvant chemoradiotherapy before radical surgery followed combined with adjuvant treatment. Approximately 15% to 20% of the patients after nCRT can achieve a pathologic complete response (pCR)---no residual tumor is reported at histology after a standard resection. Some researchers suggest that those patients with pCR can be spared the morbidities of surgery instead by a nonoperative approach---watch- and-wait(W\&W). However, neither FDG-PET, MRI, CT, nor enteroscopy can accurately determine a pCR. EUS-FNA has been an important technique for the diagnosis of rectal cancer for its high accuracy and little harm. However, data on the TRUS-FNA for the cytologic diagnosis of pCR in rectal cancer is scarce. Our hypothesis is that adding transrectal ultrasound-guided fine needle aspiration (TRUS-FNA) compared with enteroscopy , MR, and CT alone can improve the accuracy of predicting pCR after nCRT.Therefore, the aim of the study is to assess the performance characteristics of EUS-FNA in this setting.

Conditions

EUS-FNA; Rectal Cancer; Pathological Complete Remission

Outcome Measures

Primary Outcomes (1)

• the accuracy of predicting pCR after nCRT

  The primary endpoint was the predictive yield of TRUS-FNA for pathological complete responses after neoadjuvant treatment.

  25/05/2021-25/05/2022

Study Arms (1)

1

Those patients with rectal cancer after neoadjuvant treatment and completed the examination of TRUS-FNA, TRUS, CT, MR, enteroscopy and superficial biopsy

Device: TRUS-FNA

Interventions

TRUS-FNA DEVICE

Transrectal Ultrasound Guided Fine Needle Aspiration for rectal tumor

1

Eligibility Criteria

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

Study Population

all of the patients are from the sixth affiliated hospital of Sun Yet-sen University

You may qualify if:

• a new diagnosis of histologically confirmed rectal adenocarcinoma
• tumor located below the peritoneum reflex
• over 18 years old
• T1-4,N0-2,M0 before nCRT
• complete nCRT treatment
• ASA\>III or ECOG\>1
• informed consent

You may not qualify if:

• multiple primary colorectal cancer
• the history of malignant tumor,IBD,FAP
• the history of chemoradiation treatment or resection of rectal tumor
• actue abdomen disease requiring emergency surgery
• not be able to tolerate surgery with severe organ dysfunction

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• luo yanxin, MD,PHD

  the sixth affiliated hospital of Sun Yet-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 31, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)