A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Minimally Invasive Surgery Center

About this trial

This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, male or infertile female

Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy

Neoadjuvant therapy according to guideline recommendations

Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing

Disqualifiers

Samples are not collected, stored, or processed in accordance with specified requirements

Sample does not meet the requirements for subsequent RNA-seq testing

Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.

The patient refuses or is unable to complete the entire neoadjuvant treatment

Trial population

Rectal cancer patients intended for neoadjuvant therapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

118 Participants
are grouped into 1 trial group
Group A: Rectal cancer patients receiving neoadjuvant therapy

Trial outcomes

Primary outcomes

1

Objective Response Rate

The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame
From the start of the neoadjuvant therapy until just before surgery

Secondary outcomes

1

Overall survival

The time from the start of treatment to death due to any cause.

Time frame
3 years
2

Progression free survival

The period from the date of beginning treatment until the date of disease progression or death from any cause

Time frame
3 years
3

Total resection rate

Surgically removed tissue without residual cancer cells

Time frame
One month after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: