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NCT Number: NCT04743102

Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer

Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location status: Recruiting

Location contact

Jiagang Han

CONTACT

[email protected]

86-0-13522867841

Zhenjun Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male and female, between 18 and 80 years old;
  • Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
  • The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
  • The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
  • Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
  • CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal.
  • Signing informed consent for surgery.

Exclusion criteria

  • Previous history of malignant colorectal tumor;
  • Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
  • Unresectable lymph node metastasis;
  • Recently diagnosed with other malignant tumors;
  • Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
  • ASA rating ≥IV and/or ECOG physical status score ≥2 points;
  • Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;
  • a history of serious mental illness;
  • pregnant or lactating women;
  • Those with uncontrolled infection;
  • Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study

Treatment and study plan

multi-points and full-thickness Biopsy

Procedure

Four points around the tumor site and center of the tumor site full-thickness Biopsy

traditional cCR

Diagnostic Test

diginal examination, endoscopy test, rectal MRI, and serum CEA level

Primary outcomes

  1. Clinical Complete Response rate

    Time frame: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer

    Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer

  2. pathological complete remission

    Time frame: 2 weeks after patients received radical operation

    No tumor cell found in surgical specimens

Secondary outcomes

  1. Disease Free Survival

    Time frame: 5 years after operation or "watch and wait" approach

    no tumor regrowth or recurrence or metastasis found

  2. Overall Survival

    Time frame: 5 years after operation or "watch and wait" approach

    survive during following

Study contacts

Contact information is provided by the study sponsor or research team.

Jiagang Han

CONTACT

[email protected]

86-10-85231604

Zhiwei Zhai

CONTACT

[email protected]

86-10-85231604

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer

Acronym: BIOPSY

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Feb 8, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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