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NCT04939103
TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer
trial testing TRUS-FNA in EUS-FNA in 63 participants. Completed in 31 July 2022.
1 June 2022
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 63 |
| Start date | 1 July 2021 |
| Primary completion | 1 June 2022 |
| Estimated completion | 31 July 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- TRUS-FNA
Conditions studied
- EUS-FNA — all drugs for EUS-FNA →
- Rectal Cancer — all drugs for Rectal Cancer →
- Pathological Complete Remission — all drugs for Pathological Complete Remission →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
18 and older, any sex, with EUS-FNA or Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04939103 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 1 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04939103.
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